Clinical Research Nurse - Mid-Atlantic Permanente Medical Group - Largo, MD   
Investigator CVs, financial disclosure forms, laboratory certifications, radiation safety exemptions, FDA 1572 forms, etc....
From Mid-Atlantic Permanente Medical Group - Wed, 22 Mar 2017 10:28:47 GMT - View all Largo, MD jobs
          Program Coordinator, FDA and Third Party Tobacco Retail Inspection Program - JBS International, Inc. - Maryland   
Experience in conducting data analysis, preferably using SQL server databases. A Bachelor's degree, in business administration, public administration, criminal...
From JBS International, Inc. - Fri, 02 Jun 2017 03:23:28 GMT - View all Maryland jobs
          Comment on On Your Marks GETSET: Don’t Go – Major Graded Exercise ME/CFS Trial Underwhelms (Again) by jimmy   
yes this is flawed for sure.I think it is very dangerous to call this rral science or medicine. We have bad days and worse days and although we know some things that can make us worse, we still have no idea why other non eventfyl days make us sicker. We can not control our bodies even if the theory held any truth which it does not and definitely has not been proven. If we used this evidence to approve a drug for the disease the FDA would laugh at us. This disease is so complex this is an easy sill and dangerous answer. If I take a 2 hour car ride to doctor im sick for a week in bed. I have had 2 cancers from this disease. This is an insult to us all sets us back to pre historic. There are no good responses to this to argue any validaty for this. I think ill come up with a theory oh here it is playing scrabble with friends built up from 5 minutes to one hour over the next year will make me stop getting cancers from this disease, What about many of us who are bed bound or worse? This is a very serious dangerous path no matter how you rationalize this line of thinking.Please Cort this nidoes not help us only hurts us. We have gone through so much with this disease for decades we must be very very clear here that this is bad to even mention as our detractors will run with this as we have seen so many times in the past. BAD idea bad science bad for us dying everyday. the theory is bordering on nonsense. I would love to know how patients wre diagnosed and how much they improved Why wre no very sick patients used and I can gurantee you from having this disease its BS. Sorry but this will not help any one only hurt us so I apologize for my passion in advance
          Now in Effect: Iowa Right to Try Act Rejects Some FDA Restrictions on Terminal Patients   
DES MOINES, Iowa (July 1, 2017) – Today, a new Iowa law goes into effect that sets the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients. The Senate Commerce Committee sponsored Senate Bill 404 (SF404). The new law will enable terminally…
          TempTraq Wearable Wireless Thermometer   

Direct link to article... [littlegreenfootballs.com]

YouTube

TempTraq: the only available wearable, wireless, intelligent thermometer in the form of a soft comfortable patch, that continuously monitors temperatures and provides convenient alerts to give parents peace of mind and their sick children the rest they need to get better. Pending FDA premarket review. For more information visit www.temptraq.com

This sounds like a real game-changer for health monitoring ability at home. Being able to access and monitor the temperatures of your sick children, spouses, relatives, etc. from an app on your phone is a brilliant idea.


          Quality Control Clerk for a Fortune 500 Company   
WA-Bothell, Randstad has an exciting opportunity with a very recognizable Fortune 500 Company! This is an excellent entry level position for a candidate who is looking for a career track. In this role you will be responsible for service record review ensuring quality of records; identifying potential FDA reportable events and/or Business Unit follow up and escalation. This role is also responsible for corresp
          Quality Control Clerk for a Fortune 500 Company   
WA-Bothell, Randstad has an exciting opportunity with a very recognizable Fortune 500 Company! This is an excellent entry level position for a candidate who is looking for a career track. In this role you will be responsible for service record review ensuring quality of records; identifying potential FDA reportable events and/or Business Unit follow up and escalation. This role is also responsible for corresp
          Costa Mesa, CA Reason #194 Why Booking Your Happi.com Liposome Personal Care Product Development (Lotion) with Draper-Based 'Wasatch Labs' (WasatchContractManufacturing.com) Is a Professional Cosmetic Decision   

Costa Mesa, CA -- (SBWIRE) -- 06/30/2017 -- Wasatch Product Development is focused on providing the most responsive and flexible service in the industry and has a diverse clientele ranging from leading global companies to virtual and emerging entities. With unmatched technical expertise, innovative equipment and regulatory knowledge, Wasatch maintains a demonstrated record with the FDA as well as with its customers; many of whom have outsourced with the company for over ten years. The Wasatch Product Development's lab is compliant with Good Manufacturing Practices (cGMP) along with being registered and certified by the ATF, and FDA. Wasatch has been developing and manufacturing several unique products for many of the World's most successful consumer product companies since 1998.

Contact COO Adam Green Today!
c: 801-809-7766
e: ops@WasatchContractManufacturing.com

- Get a Quote Now! 
http://wasatchcontractmanufacturing.com/contact-us/

Mission Statement
To proactively serve our business community by providing solutions in personal care, business development and liquid nutrition.

Vision Statement
To provide leadership in establishing our client's international businesses, being built on a foundation of innovation, advocacy, technology and business integrity.

http://wasatchcontractmanufacturing.com/

~Wasatch Labs' Core Competencies are:

Anti-Aging
Gene Expression
Neuro-Peptides
Cosme-ceuticals (Skin Care)
Skin "Energy Systems"
OTC Products (Sanitizers, SunScreens, etc)
SPF: Sun Protection
Liquid Nutritionals and Juices
Unique Skin Treatments (Intimacy, Sanitation, and "plumping" products)

Think of Wasatch Labs when you are considering sourcing a secondary manufacturer for your existing products or perhaps a reliable, experienced laboratory for product development.

~Wasatch Lab's Competitive Advantages include:

In-House Capabilities (Packaging Engineering, Formula Development, Manufacturing)
International Capabilities
Total Customer Support
Complete Supply Chain Management
cGMP

Thanks for Stopping By – WPG – HOME Tab
https://vimeo.com/75658706

Whatever the size of the anti-aging product corporation, Wasatch Contract Manufacturing can take it to the next level. They provide packaging engineering, formula development, private labeling, and manufacturing of liquid products. Small Companies: They help small companies identify their industry niche, develop proprietary formulas, and make a strong debut on the market. Many of their current Salt Lake City start-ups are focused on emerging Utah and national markets: gene expression, skin energy systems, specialty sun care, and anti-aging.

Medium Size Companies: Wasatch helps medium companies refine their product lines, improve quality, and manage production growth.

Large Utah Companies: They help large companies diversify and respond to changes in the market. Many large companies are developing new product lines in high-demand mitochondrial anti-senescence, neuro peptides, and acne products. Wasatch Contract Manufacturing is a cGMP, FDA, EPA, and ATF compliant facility. Wasatch has been formulating liquid products for over twenty years without an FDA violation. Call their operations manager today to learn how Wasatch can help a company move forward.

About Wasatch Product Development
Wasatch Product Development is focused on providing the most responsive and flexible service in the industry and has a diverse clientele ranging from leading global companies to virtual and emerging entities. With unmatched technical expertise, innovative equipment and regulatory knowledge, Wasatch maintains a demonstrated record with the FDA as well as with its customers; many of whom have outsourced with the company for over ten years. The Wasatch Product Development's lab is compliant with Good Manufacturing Practices (cGMP) along with being registered and certified by the ATF, and FDA. Wasatch has been developing and manufacturing several unique products for many of the World's most successful consumer product companies since 1998.

http://wasatchcontractmanufacturing.com/

For more information on this press release visit: http://www.sbwire.com/press-releases/costa-mesa-ca-reason-194-why-booking-your-happicom-liposome-personal-care-product-development-lotion-with-draper-based-wasatch-labs-wasatchcontractmanufacturingcom-is-a-professional-cosmetic-decision-827038.htm

Media Relations Contact

Adam Green
Wasatch Contract Manufacturing
Telephone: 801-809-7766
Email: Click to Email Adam Green
Web: http://wasatchcontractmanufacturing.com


          Corona, CA Reason #195 Why Outsourcing Your Happi.com Liposome Anti-Aging Product Development (Creme) with Draper-Based 'Wasatch Labs' (WasatchContractManufacturing) Is a Professional Cosmetic Decision   

Corona, CA -- (SBWIRE) -- 06/30/2017 -- Wasatch Product Development is focused on providing the most responsive and flexible service in the industry and has a diverse clientele ranging from leading global companies to virtual and emerging entities. With unmatched technical expertise, innovative equipment and regulatory knowledge, Wasatch maintains a demonstrated record with the FDA as well as with its customers; many of whom have outsourced with the company for over ten years. The Wasatch Product Development's lab is compliant with Good Manufacturing Practices (cGMP) along with being registered and certified by the ATF, and FDA. Wasatch has been developing and manufacturing several unique products for many of the World's most successful consumer product companies since 1998.

Contact COO Adam Green Today!
c: 801-809-7766
e: ops@WasatchContractManufacturing.com

- Get a Quote Now! 
http://wasatchcontractmanufacturing.com/contact-us/

Mission Statement
To proactively serve our business community by providing solutions in personal care, business development and liquid nutrition.

Vision Statement
To provide leadership in establishing our client's international businesses, being built on a foundation of innovation, advocacy, technology and business integrity.

http://wasatchcontractmanufacturing.com/

~Wasatch Labs' Core Competencies are:

Anti-Aging
Gene Expression
Neuro-Peptides
Cosme-ceuticals (Skin Care)
Skin "Energy Systems"
OTC Products (Sanitizers, SunScreens, etc)
SPF: Sun Protection
Liquid Nutritionals and Juices
Unique Skin Treatments (Intimacy, Sanitation, and "plumping" products)

Think of Wasatch Labs when you are considering sourcing a secondary manufacturer for your existing products or perhaps a reliable, experienced laboratory for product development.

~Wasatch Lab's Competitive Advantages include:

In-House Capabilities (Packaging Engineering, Formula Development, Manufacturing)
International Capabilities
Total Customer Support
Complete Supply Chain Management
cGMP

Thanks for Stopping By – WPG – HOME Tab
https://vimeo.com/75658706

Whatever the size of the anti-aging product corporation, Wasatch Contract Manufacturing can take it to the next level. They provide packaging engineering, formula development, private labeling, and manufacturing of liquid products. Small Companies: They help small companies identify their industry niche, develop proprietary formulas, and make a strong debut on the market. Many of their current Salt Lake City start-ups are focused on emerging Utah and national markets: gene expression, skin energy systems, specialty sun care, and anti-aging.

Medium Size Companies: Wasatch helps medium companies refine their product lines, improve quality, and manage production growth.

Large Utah Companies: They help large companies diversify and respond to changes in the market. Many large companies are developing new product lines in high-demand mitochondrial anti-senescence, neuro peptides, and acne products. Wasatch Contract Manufacturing is a cGMP, FDA, EPA, and ATF compliant facility. Wasatch has been formulating liquid products for over twenty years without an FDA violation. Call their operations manager today to learn how Wasatch can help a company move forward.

About Wasatch Product Development
Wasatch Product Development is focused on providing the most responsive and flexible service in the industry and has a diverse clientele ranging from leading global companies to virtual and emerging entities. With unmatched technical expertise, innovative equipment and regulatory knowledge, Wasatch maintains a demonstrated record with the FDA as well as with its customers; many of whom have outsourced with the company for over ten years. The Wasatch Product Development's lab is compliant with Good Manufacturing Practices (cGMP) along with being registered and certified by the ATF, and FDA. Wasatch has been developing and manufacturing several unique products for many of the World's most successful consumer product companies since 1998.

http://wasatchcontractmanufacturing.com/

For more information on this press release visit: http://www.sbwire.com/press-releases/corona-ca-reason-195-why-outsourcing-your-happicom-liposome-anti-aging-product-development-creme-with-draper-based-wasatch-labs-wasatchcontractmanufacturing-is-a-professional-cosmetic-decision-827039.htm

Media Relations Contact

Adam Green
Wasatch Contract Manufacturing
Telephone: 801-809-7766
Email: Click to Email Adam Green
Web: http://wasatchcontractmanufacturing.com


          Cottonwood West, UTAH Reason #192 Why Outsourcing Your Happi.com Liposome Personal Care Product Development (Cleanser) with Utah-Based 'Wasatch Labs' (WasatchContractManufacturing.com) Is a Wise Cosmetic Decision   

Cottonwood West, UT -- (SBWIRE) -- 06/29/2017 -- Wasatch Product Development is focused on providing the most responsive and flexible service in the industry and has a diverse clientele ranging from leading global companies to virtual and emerging entities. With unmatched technical expertise, innovative equipment and regulatory knowledge, Wasatch maintains a demonstrated record with the FDA as well as with its customers; many of whom have outsourced with the company for over ten years. The Wasatch Product Development's lab is compliant with Good Manufacturing Practices (cGMP) along with being registered and certified by the ATF, and FDA. Wasatch has been developing and manufacturing several unique products for many of the World's most successful consumer product companies since 1998.

Contact COO Adam Green Today!
c: 801-809-7766
e: ops@WasatchContractManufacturing.com

- Get a Quote Now! 
http://wasatchcontractmanufacturing.com/contact-us/

Mission Statement
To proactively serve our business community by providing solutions in personal care, business development and liquid nutrition.

Vision Statement
To provide leadership in establishing our client's international businesses, being built on a foundation of innovation, advocacy, technology and business integrity.

http://wasatchcontractmanufacturing.com/

~Wasatch Labs' Core Competencies are:

Anti-Aging
Gene Expression
Neuro-Peptides
Cosme-ceuticals (Skin Care)
Skin "Energy Systems"
OTC Products (Sanitizers, SunScreens, etc)
SPF: Sun Protection
Liquid Nutritionals and Juices
Unique Skin Treatments (Intimacy, Sanitation, and "plumping" products)

Think of Wasatch Labs when you are considering sourcing a secondary manufacturer for your existing products or perhaps a reliable, experienced laboratory for product development.

~Wasatch Lab's Competitive Advantages include:

In-House Capabilities (Packaging Engineering, Formula Development, Manufacturing)
International Capabilities
Total Customer Support
Complete Supply Chain Management
cGMP

Thanks for Stopping By – WPG – HOME Tab
https://vimeo.com/75658706

Whatever the size of the anti-aging product corporation, Wasatch Contract Manufacturing can take it to the next level. They provide packaging engineering, formula development, private labeling, and manufacturing of liquid products. Small Companies: They help small companies identify their industry niche, develop proprietary formulas, and make a strong debut on the market. Many of their current Salt Lake City start-ups are focused on emerging Utah and national markets: gene expression, skin energy systems, specialty sun care, and anti-aging.

Medium Size Companies: Wasatch helps medium companies refine their product lines, improve quality, and manage production growth.

Large Utah Companies: They help large companies diversify and respond to changes in the market. Many large companies are developing new product lines in high-demand mitochondrial anti-senescence, neuro peptides, and acne products. Wasatch Contract Manufacturing is a cGMP, FDA, EPA, and ATF compliant facility. Wasatch has been formulating liquid products for over twenty years without an FDA violation. Call their operations manager today to learn how Wasatch can help a company move forward.

About Wasatch Product Development
Wasatch Product Development is focused on providing the most responsive and flexible service in the industry and has a diverse clientele ranging from leading global companies to virtual and emerging entities. With unmatched technical expertise, innovative equipment and regulatory knowledge, Wasatch maintains a demonstrated record with the FDA as well as with its customers; many of whom have outsourced with the company for over ten years. The Wasatch Product Development's lab is compliant with Good Manufacturing Practices (cGMP) along with being registered and certified by the ATF, and FDA. Wasatch has been developing and manufacturing several unique products for many of the World's most successful consumer product companies since 1998.

http://wasatchcontractmanufacturing.com/

For more information on this press release visit: http://www.sbwire.com/press-releases/cottonwood-west-utah-reason-192-why-outsourcing-your-happicom-liposome-personal-care-product-development-cleanser-with-utah-based-wasatch-labs-wasatchcontractmanufacturingcom-is-a-wise-cosmetic-decision-825864.htm

Media Relations Contact

Adam Green
Wasatch Contract Manufacturing
Telephone: 801-809-7766
Email: Click to Email Adam Green
Web: http://wasatchcontractmanufacturing.com


          Cottonwood Heights, UTAH Reason #193 Why Sourcing Your Happi.com Liposome Skin Care Product Development (Moisturizer) with Utah-Based 'Wasatch Labs' (www.WasatchContractManufacturing.com) is a Wise Cosmetic Decision   

Cottonwood Heights, UT -- (SBWIRE) -- 06/29/2017 -- Wasatch Product Development is focused on providing the most responsive and flexible service in the industry and has a diverse clientele ranging from leading global companies to virtual and emerging entities. With unmatched technical expertise, innovative equipment and regulatory knowledge, Wasatch maintains a demonstrated record with the FDA as well as with its customers; many of whom have outsourced with the company for over ten years. The Wasatch Product Development's lab is compliant with Good Manufacturing Practices (cGMP) along with being registered and certified by the ATF, and FDA. Wasatch has been developing and manufacturing several unique products for many of the World's most successful consumer product companies since 1998.

Contact COO Adam Green Today!
c: 801-809-7766
e: ops@WasatchContractManufacturing.com

- Get a Quote Now! 
http://wasatchcontractmanufacturing.com/contact-us/

Mission Statement
To proactively serve our business community by providing solutions in personal care, business development and liquid nutrition.

Vision Statement
To provide leadership in establishing our client's international businesses, being built on a foundation of innovation, advocacy, technology and business integrity.

http://wasatchcontractmanufacturing.com/

~Wasatch Labs' Core Competencies are:

Anti-Aging
Gene Expression
Neuro-Peptides
Cosme-ceuticals (Skin Care)
Skin "Energy Systems"
OTC Products (Sanitizers, SunScreens, etc)
SPF: Sun Protection
Liquid Nutritionals and Juices
Unique Skin Treatments (Intimacy, Sanitation, and "plumping" products)

Think of Wasatch Labs when you are considering sourcing a secondary manufacturer for your existing products or perhaps a reliable, experienced laboratory for product development.

~Wasatch Lab's Competitive Advantages include:

In-House Capabilities (Packaging Engineering, Formula Development, Manufacturing)
International Capabilities
Total Customer Support
Complete Supply Chain Management
cGMP

Thanks for Stopping By – WPG – HOME Tab
https://vimeo.com/75658706

Whatever the size of the anti-aging product corporation, Wasatch Contract Manufacturing can take it to the next level. They provide packaging engineering, formula development, private labeling, and manufacturing of liquid products. Small Companies: They help small companies identify their industry niche, develop proprietary formulas, and make a strong debut on the market. Many of their current Salt Lake City start-ups are focused on emerging Utah and national markets: gene expression, skin energy systems, specialty sun care, and anti-aging.

Medium Size Companies: Wasatch helps medium companies refine their product lines, improve quality, and manage production growth.

Large Utah Companies: They help large companies diversify and respond to changes in the market. Many large companies are developing new product lines in high-demand mitochondrial anti-senescence, neuro peptides, and acne products. Wasatch Contract Manufacturing is a cGMP, FDA, EPA, and ATF compliant facility. Wasatch has been formulating liquid products for over twenty years without an FDA violation. Call their operations manager today to learn how Wasatch can help a company move forward.

About Wasatch Product Development
Wasatch Product Development is focused on providing the most responsive and flexible service in the industry and has a diverse clientele ranging from leading global companies to virtual and emerging entities. With unmatched technical expertise, innovative equipment and regulatory knowledge, Wasatch maintains a demonstrated record with the FDA as well as with its customers; many of whom have outsourced with the company for over ten years. The Wasatch Product Development's lab is compliant with Good Manufacturing Practices (cGMP) along with being registered and certified by the ATF, and FDA. Wasatch has been developing and manufacturing several unique products for many of the World's most successful consumer product companies since 1998.

http://wasatchcontractmanufacturing.com/

For more information on this press release visit: http://www.sbwire.com/press-releases/cottonwood-heights-utah-reason-193-why-sourcing-your-happicom-liposome-skin-care-product-development-moisturizer-with-utah-based-wasatch-labs-wwwwasatchcontractmanufacturingcom-is-a-wise-cosmetic-decision-825865.htm

Media Relations Contact

Adam Green
Wasatch Contract Manufacturing
Telephone: 801-809-7766
Email: Click to Email Adam Green
Web: http://wasatchcontractmanufacturing.com


          özbek esirler...   

dua...dua...dua

Özbekistan'da bir cezaevindeki Müslüman Kadın mahkumlardan gelen mektup: "Kardeşlerim sesimizi bütün Müslümanlara duyurun !"

Shamil-Online editörüne bugün (13.Temmuz.Çarşamba) sabah Özbekistan kukla yönetimi Karimov rejimi tarafından tutuklanarak cezaevlerinde zulüm gören Müslüman kız kardeşlerimizin durumunu anlatan bir mektup ulaştırıldı.
Mektubu Shamil-Online web sitemize ulaştıran kardeşimiz şöyle diyor:
«Selam aleykum kardeşim. Bu mektup bize Özbekistanda ceza evinde zulüm gören bacılarımız tarafından ulaştırıldı ve bu mektuplardan daha bir kaç tane daha var. İnşaallah bacılar istiyorlar bu mektupları yayınlayın ve Ümmet bizim halimizi görsün ve bize yardım etsin» diyorlar.

Size gönderdiğim bu mektup Özbekistan kadınlar cezaevinde yazıldı ve dışarıya gönderildi.
Kadinlar hapishanesinden İslam Karimov yani ( Özbekistan Cumhurbaşkani diktatör Gestapo rejimini belirtmekte istiyoruz) bu diktator hükümetinin bu müthiş azabhanade bugun 25 Müsliman kadın Rabbim Allah dedikleri icin perişan halde ve işkence altında gün geçirmekteler..
Bunlar normal mahkum degiller bunlar için Karimov'un söylediklerine göre ve verdigi açiklamalara göre «bizim kadınlarla hiç bir problemimiz yok demişdi ama bu Müslimanların anlattıklerine göre «bizler normal mahkumlar deyiliz... her kes için normalde af çıkarılsa da ve bütün kim varsa tahliya olsa da bunlar için afda yok veya tahliye olmalarının hiç mümkünatı da yoktur.. bunlar için azab şiddet,işkence ve tecavüz yapılmaktadır..»
Bunlar elimize cezaevinden gönderdikleri mektupta şöyle sesleniyorlar !
* * *
Bismillahi Rahmanir Rahim.
Assalamu Aleykum kardeşlerim !
ilk once sizlerin hepinizin bütün Müslüman Ümettinin mübarek ayı Ramazan ayınızı tebrik ediyoruz  ve cahiliyetten kurtulan kardeşlerimizin ahirette de nurlu bir hayat yaşamasını ümid ediyorum.
Rabbimiz olan Allah bütün iman eden kullarını mustaqim yolundan ayrılmamamız için bizlere kuvvet tavfik versin.
Mümineler (Kadın Müslümanlar) yaradan Allah'a iman getirdikleri icin her türlü şiddet ve fiziki güce maruz kalmakta dövülerek cezaevlerinde katledilmektedir.
Biz ise Allah'ın dinine düşmanlık edenleri sadece Allah'a havale ediyoruz gücümüz cezaevinde bu kadar. Yüce Allah bilici ve görücüdür.

Sevgili dindaş kardeşlerim !
Bu maktubi size Özbekistan Müslümanları yollamaktadir.
Bu mektubu isterseniz beyan diye kabul edin veya isterseniz bir müracaat olarak kabul edin.
Bizim maksadımız elerinde az bir imkanı olan varsa veya baska bir sekilde olsun sesimizi duyursun. Erkek kardeşlerimizin namus meselesidir. Allah aşkına Kız kardeşlerinizi bu çirkin sistemin ve bu rejimin kafirlerinin ellerinde rezil olmamızı hiç birinizin istemediginizi ve bir şekilde yardım edeceginizin ümidindeyiz !

Su an kovusta toplam 25 Müslüman kadın bulunmaktayiz.
Bunlardan 17'si Sunni insha'Allah: Peygemberimiz Muhammad'in (s.a.v) Sünnetinde bir oldumuz için ve Sünneti Rasulullaha amel ettiğimiz için burada birlik olmaktayız.
Buradaki rejimin sistemini düzenleyen (ÖZBEKISTAN CEZA KANUNUNA GORE 159-maddesi) hepimize diğer mahkümlardan farklı muamele yapılıyor ve çok agir ve sert şartlarda bize  davranilir.
50 yaşından büyük olmasına bakmayarak kışın soğuk günlerde bile veya yazın en sıcak günlerinde iş olsa da olmasa da hergün sabah 06:00 kaldırıp değişik ve ağır işlerde bizi çalıştırırlar. Burada bu şekilde çalıştırılmaktan hepimiz çeşitli hastalıklara yakalandık ve bir kısmımız hala hasta.
Etibar isimli bir kadın Müslüman kendisi 45 yaşında böbrek kanseri hastalığına yakalandı. Bu Müslüman kadın kardeşimiz hastaneye götürüldü fakat ertesi gün geri gönderildi. Sebebi de 159.maddeden mahkum olması.
Adina isimli bir başka Müslüman ablamız 41 yaşında. Bu ablamızın sürekli ateşi yükselir. Hastaneye tedavi için gönderildi fakat analiz yaptığını söyleyen Karimov rejimi doktoru bir şeyi yok dedi ve cezaevine geri gönderildi.
Hastanede çalışan doktorlar olsun veya hastane müdürü olsun herkes 159.maddeden cezaevinde hapis yatanlara yardım ediyor diye şikayet edilmekten korkuyor ve rejim ile başlarının derde girmemesi için gelen hastayı hemen cezaevine geri gönderiyor. 
Ayrıca Özbekistan'da cezaevinde Dini kitapların hiç birine izin verilmiyor. Ellerimizdek Kur'an Kerim'ler toplandı Kur'an'ı Kerim'i legal olmayan yollardan içeri sokmaya sokmaya çalışırken yakalanırsa cezası ağırdır ve bunun resmi müdürü yok diye geri alınır. zaten legal yani resmi yollar bizim için kapalıdır. Fakat normal de İslama zıd olan ne kadar neşriyat varsa göz yumulur ve legal olmayan yolda olsa rejim görmezden gelir. Kısaca Dinimize zıd olan herşeyi bulmak çok kolaydır.
Bu sistemde çalışan rejimin adamları bizim için legal olsun olmasın İslam hakkında bir şey söyler ve sisteme karşı gelerek seslenirse tamam en ağır işkence ve fiziki eziyet başlıyor demektir. Cezaevinde boş bir odaya alıp götürürler ve o oda içinnde yapmadiklari işkence kalmaz. Elbiseleri tamam çıkartılır ve oturup kalkmasını isterler ve her türlü fiziki işkenceler yapılarak tecavüz ederler.
Biraz sesimizi yükseltirip kendi haklarımızı istemeye,talep etmeye çalışırsak sisteme karşı geliyor sistemi taciz ediyor diye hücreye götürüp her türlü işkence yapmaya günlerce devam ederler.
21 yaşında Mukaddas isimli kız kardeşimiz var onu cezaevi müdürlügü çagirdi ve ona «bunlardan vazgeç sen onların arasına girme daha gençsin» diyerek onu kandırmaya çalıştılar. «Sana çok üzülüyoruz daha gençsin ve eğer dediklerimiz yaparsan en kısa zamanda seni evine göndereceğiz» demişler. Fakat sonra kır kardeşimizden «Hayır» cevabını duyunca ona çok üzülen ve en kısa zamanda evine gönderecek olan cezaevi rejimi onu sisteme karşı geldi diye 5 kez hücreye gönderdi ve değişik işkenceler ile acı çektirdi. Kız kardeşimiz zaten midesinden ve böbreklerinden hasta idi ve vücudunun kemikleri görünecek kadar da zayıftır fakat burada kimse bize sahip çıkmaz. Sahip çıkacaklara da içeri ile irtibat sağlamasına engel konulur.
Evet benim Din Kardeşlerim, söylersem daha çok şeyler var söylenecek bize burada böyle zulüm edilmektedir. Kadın Müslüman tutukluların 17 yaşından küçük yada yaşlı olduğuna bakılmaksızın tek suçumuz  «Dinimiz İslam» dediğimiz için bizi buraya mühürleyip hapsettiler. Aftan faydalanmayalım diye de hakkımızda çeşitli asılsız suçlar icad etmekteler.
Belki bu mektubum elinize ulaşırsa Mü'min ve Müslüman kardeşlerim birleşir ve Allah'ın inayeti ile özgürlüğümüzü kazanıp ailelerimize kavuşmamız için bize yardımcı olun insh'Allah.
Assalamu Aleykum va Rahmatullah!

          Letter to the editor regarding "GRAS from the ground up: Review of the Interim Pilot Program for GRAS notification" by.   

Letter to the editor regarding "GRAS from the ground up: Review of the Interim Pilot Program for GRAS notification" by.

Food Chem Toxicol. 2017 Jun 26;:

Authors: Sewalt V, LaMarta J, Shanahan D, Gregg L, Carrillo R

Abstract
Present letter is aimed at clarifying some critical points highlighted by Hanlon et al. regarding the common knowledge element of the safety of food enzymes in support of their GRAS designation. Particularly, we outline the development of peer-reviewed, generally recognized safety evaluation methodology for microbial enzymes and its adoption by the enzyme industry, which provides the US FDA with a review framework for enzyme GRAS Notices. This approach may serve as a model to other food ingredient categories for a scientifically sound, rigorous, and transparent application of the GRAS concept.

PMID: 28663033 [PubMed - as supplied by publisher]


          FDA moves signal storm warning for pharma firms   
Regulator to expedite approvals for generics to damp prices
          Say Hello to All Natural Makeup   
Though makeup uplifts the appearance of women, little do these women know that applying makeup can expose them to hundreds of chemicals. So the beautiful appearance that makeup can give you is only temporary. Constant exposure to chemicals found in cosmetics can give you long-term effects. Lipstick, eye shadows, foundations, creams and other forms of makeup are said to contain toxic chemicals that are said to cause cancer and infertility. These are not just simple medical conditions as cancer can even take someone else's life. Because this is an alarming situation, the Food and Drug Administration or the FDA has set standards and regulations for the manufacture of cosmetic products. This way, everyone can guarantee that the makeup they are using could not compromise their health and also their skin. If a certain product has not undergone the rigorous testing and does not passed the standards set by the FDA, distribution of these products may be considered illegal. According to the rules set by law, the "FDA does not have the authority to approve cosmetic products or ingredients, except for color additives.This is why the development of all natural makeup is very important. "With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may, on his own responsibility, use essentially any raw material as a cosmetic ingredient and market that product without approval. "Although not prohibited by law or regulation, in addition, the manufacturers of cosmetic fragrance products have voluntarily agreed to not use or to limit maximum use levels of certain selected ingredients which have been found to cause depigmentation, irritant, neurotoxic or phototoxic or other allergic reactions." The setting of this rule has paved the way for the introduction of all natural makeup. Many of this kind of makeup have proliferated in the industry because of the manufacturer's fear that FDA would not approve their products. Because the products they offer have great benefits to women who are using makeup, there is now a rave in the market for women all wanting to own an all natural makeup. As the name suggests, you won't ever encounter any harmful ingredient or chemical mixed in the makeup. And yes, your health and your skin will be properly taken care of. You don't have to worry on the makeup's effect on your skin and you can now say goodbye to pimples. It is said that makeup with excessive amount of chemical can also affect your sensitive skin. The skin, especially on the face, can develop allergies and other skin problems once constantly exposed to harmful makeup chemical. And of course, the deadly effects of chemicals on makeup can only be observed after the prolong usage of makeup on your face. But even your makeup is an all natural makeup, its quality is never compromised. You can still get the same look as the makeup that uses chemicals. You can still find one with all the exciting and vibrant colors. Also, their function on your face will only provide a more beautiful and sophisticated new you.

Learn about Philosophy Cosmetics, which is a popular web site that provides tips and advice on the best cosmetics including the philosophy cosmetic product range.
          Astellas submits sNDA with the US FDA for the mirabegron and solifenacin succinate combination for the treatment of overactive bladder   
none
          Device Week Podcast - Episode 100   
On this week's 100th Medtech Insight podcast: a new value-based reimbursement scheme emerges between Medtronic and Aetna; a major escalation in cybersecurity threats to medical devices concerns industry; the US Senate plans to keep the device tax repeal in its reworked health-care bill; a look at US FDA funding; two innovative device companies are spotlighted; medtech legal advocates want to bring FDA’s 510(k) process before the Supreme Court; virtual reality therapy gains traction.
          Beach Beat: Why ask why? Because you have a right to know   
This started out to be a news story about how the FDA and DOJ did that thing they do this week — protect the public interest — when they closed down a smoked fish company in New York that had been endangering people’s lives for at least six years. But we brought you that story... Continue Reading
          Comment on Is your “healthy” milk alternative making you sick? by spokesnoats   
Debbie, I appreciate your feedback. I did say, "Wiki addresses carrageenan’s safety as controversial, yet suggests it more than likely induces gastrointestinal issues and disease" in this post. I agree with you...the verdict is still out. I'd rather be safe than sorry. We have a history of blindly ingesting things that are FDA approved and controversial, yet later on down the line the pendulum swings to the side of causing harm.
          28 MAYO 2017   



  • - IMPORTACION MARITIMA, PUERTO DEL CALLAO

    IMPORTACIONES CALLAO: EXPORTADORES
    FECHA: 28 MAYO 2017(CALLAO)
    BUQUE: ARKADIA


    ORIGEN..¦EXPORTADOR..........¦PRODUCTO..............................................................¦KILOS
    SAN ANTONIO
    ANTALIS CHILE LIMITADA.............¦TINTA AMSTRONG COLOR: NEGRO EN TARRO DE 1KG NEGRO PROCESO ARMSTRONG -.¦6877
    AUTOMOTORES ECASO SA...............¦CAJA DE ALIMENTACION INFERIOR FLSMIDTH DE ACERO PARTES Y PIEZAS PARA M¦7980
    CARLOS CRAMER PRODUCTOS AROMATICOS.¦SABORIZANTE PI¥A PARA ELABORACION DE BEBIDA GASEOSA EN BIDONES 2P5113-¦684
    CASAS DEL VALLE BARROS HNOS LTDA...¦MANGA ND S/N C/GALLETA CIRCULAR QSP N.D.DIA. 120 MANGA QSP ND DIA 120.¦7076
    COBRE CERRILLOS SA.................¦CONDUCTOR ELECTRICO GENERAL CABLE RV-K 1000V SUPERFLEX RV-K 4X10 MM2 0¦36679
    COPEFRUT SA........................¦MANZANAS FRESCAS COPEFRUT MANZANAS CALIBRES:100 PARA CONSUMO HUMANO CA¦45539
    DOSIVAC SA.........................¦TUERCA AJUSTE DOSIVAC -42133/1-10 UNID................................¦11
    EDITORIAL KIER SA..................¦LIBROS SIGLO XXI ANTOLOGIA GRAMSCI (PARTE I) EDICION ESPECIAL 978-987-¦575
    EXPORTADORA EL REFUGIO LTDA........¦MANZANA LUCKY MANZANAS FRESCAS PARA CONSUMO HUMANO CAJAS DE CARTON CON¦21496
    FORD ARGENTINA SCA.................¦PROTECTOR DE CAJA FORD ACB3/2K612606/BC/REPUESTO PARA VEHICULO PROTECT¦411
    GIVAUDAN ARGENTINA SA..............¦ESENCIA FRESA GIVAUDAN INSUMO INDUSTRIA ALIMENTARIA LOTE: BU00146444 7¦1062
    GONVARRI CHILE ESTRUCTURAS METALICA¦AMORTIGUADOR DE IMPACTO HIASA AIR H-100PAMORTIGUADOR DE IMPACTOS TIP-H¦2500
    INDUSTRIA DE ALIMENTOS DOS EN UNO..¦CHOCOLATE CON RELLENO ARCOR CHOCOLATE CON RELLENOS SURTIDOS DE MANJAR.¦7458
    IXOM CHILE SA......................¦PM-700 IXOM PM-700 IBC 1200 KG NU: NA CLASE: NA 16 IBC DE 1200 KGS. CA¦41820
    MANUFACTURAS METALURGICAS RHEEM....¦TAMBOR CODIGO: F6KBBBF6J3VY000D00 USO:CALIBRE 20-20-20 COLOR VERDE SIN¦23602
    MANUFACTURAS METALURGICAS RHEEM....¦TAMBOR DE 55 GLS RHEEM COLOR ROJO SIN LOGO PARA USO COMERCIAL EN UNIDA¦23760
    MANUFACTURAS METALURGICAS RHEEM....¦TAMBOR DE 55 GLS RHEEM COLOR ROJO SIN LOGO INCLUYE SELLOS PARA USO COM¦46080
    MANUFACTURAS METALURGICAS RHEEM....¦BALDES PLASTICOS FLINT GROUP CODE: G2ER2ED1M00O4FL1M6 BD 20L R2 PE BLA¦6482
    MARIENBERG GESTORA DE NEGOCIOS LIMI¦MALLA SOMBRA MARIENBERG TE¥IDO; ACABADO:APRESTADO CONST: LIGAMENTO TAF¦7331
    MIMET S A..........................¦VITRINA VERTICAL MIMET VV-66D-03 PUERTASDESLISABLES-GAS REF: R-404A (H¦4116
    MIMET S A..........................¦CONSERVADORA MOSTRADORA MIMET CV-280IAE CONSERVADORA MOSTRADORA CV-280¦6466
    NALCO IND SERVICES CHILE LTDA......¦NALCO 650P NALCO USO INDUSTRIAL EN TAMBORES NALCO 650P AGENTE DE LIMPI¦56801
    NALCO IND SERVICES CHILE LTDA......¦NALCO 8575 NALCO ZINC ACIDO ORGANICO ACIDO FOSFORICO INDUSTRIAL BULTOS¦8752
    PACX SOUTH AMERICA SA..............¦HARINA DE ALFALFA PARA CONSUMO ANIMAL 650 SACOS DE POLIPROPILENO DE 40¦26097
    POLCURA EXPORTACIONES SAMANUEL OLEG¦MANZANAS FRESCAS MANZANA FRUTO FRESCO PARA CONSUMO HUMANO MANZANAS FUJ¦22562
    POLYGAL SUD SA.....................¦POLIC ALVEOLAR LIV POLYGAL ACABADO:LAMINADO; COLOR:CON COLOR PLASTIF:.¦12692
    PROCTER & GAMBLE CHILE LTDA........¦TELA NO TEJIDA TS FITBR 15GSM CW 168MM CD 152 4MM GR SPB EM (7 PAQUETE¦7379
    PROCTER & GAMBLE CHILE LTDA........¦PA¥ALES DESECHABLES PAMPERS 80274769 PAMPERS J&S / TC PEQ 48PADSX6IT P¦6287
    PRUNE SA...........................¦PASAS FRUTISA 10 KG X CAJA COSECHA 2017 FECHA DE ELABORACION MAYO 2017¦20486
    SC JOHNSON &SODE ARGENTINA SAIC....¦RAID DOBLE ACCION Z&M RAID 665371 INSECTICIDA DE USO DOMESTICO EN SPRA¦8351
    SOGEFI FILTRATION ARGENTINA SA.....¦FILTRO DE COMBUSTIBLE FRAM C-10353 AUTOMOTRICES PARA AUTOS / CAMIONES.¦1068
    SOUTHERN STAR SHIPPING SERVICES ON.¦LIMPIADOR CIF 15 X 450 ML PARA LIMPIEZA ANTIBACT DOYP.................¦20623
    SOUTHERN STAR SHIPPING SERVICES ON.¦SOPA KNORR 10 X 86 G PARA EL CONSUMO HUMANO SOPA VEG C/FID LETRAS.....¦15632
    SOUTHERN STAR SHIPPING SERVICES ON.¦JABON REXONA 108 X 90G PARA EL ASEO PERSONAL JAB BAMBOO FRESH.........¦21368
    TA GAS TECHNOLOGY SA...............¦KIT SIGAS 2.4 TA GAS TECHNOLOGY -KIT SIGAS 2.4+IN03 ARF+ (KIT PP 4C GN¦3992
    TECBOLT SA.........................¦ROSCALATA CABEZA MAMUT/FIXSER DE #8-18 X3/8 ROSCALATA CABEZA TRUSS PH.¦5234
    TEKEMI SA..........................¦BLINDAJE ELECTROMAGNETICO TEKEMI PARA AISLAR LA ZONA DE FUNCIONAMIENTO¦3076
    TFP PRODUCTEC SA...................¦TELA TECHNOSPIRAL METSO SPIRALTEC 7OF900D GRAMAJE= 1350 G/M2 TELA PLAS¦170
    WINPACK SA.........................¦JUMBO STRETCH FILM ACABADO:LAMINADO; COLOR:CON COLOR PLASTIF: % CALIDA¦72809
    SAN VICENTE
    COLCHONES ROSEN SAIC...............¦COLCHON ROSEN NEW STYLE 4 1.35 X 1.90 14011363 COLCHON NEW STYLE 4....¦14096
    COLCHONES ROSEN SAIC...............¦COLCHON ROSEN NEW STYLE 6 1.05 X 1.90 14011403 COLCHON NEW STYLE 6....¦3522
    COLCHONES ROSEN SAIC...............¦COLCHON ROSEN NEW STYLE 2 0.90 X 1.90 14011373 COLCHON NEW STYLE 2....¦4015
    COLCHONES ROSEN SAIC...............¦METRO TORTA EMB ROSEN NEW STYLE RELLENO FIBRA POLIESTER LAMINA POLIURE¦10262
    COLCHONES ROSEN SAIC...............¦METRO TORTA EMB ROSEN FUE FDA NEW STYLE RELLENO FIBRA POLIESTER LAMINA¦5910
    COLCHONES ROSEN SAIC...............¦MT EMB PUNZ MASIAS COL ROSEN MASIAS RETAZO DE GUATA DE FIBRAS SINTETIC¦5880
    COLCHONES ROSEN SAIC...............¦NP EMB POLI BASE ROSEN BASE AMER BASE AMER 600 GR/MT2 DIMENSIONES:105.¦7077
    COLCHONES ROSEN SAIC...............¦MT EMB PUNZ MASIAS COL ROSEN MASIAS RETAZO DE GUATA DE FIBRAS SINTETIC¦7293
    COLCHONES ROSEN SAIC...............¦BASE BOX ROSEN PREMIUM DORM 0.80 X 2.00 P/UNIR 14007328 BASE BOX PREMI¦4768
    COLCHONES ROSEN SAIC...............¦BASE BOX ROSEN PREMIUM DORM 0.80 X 2.00 P/UNIR 14007328 BASE BOX PREMI¦5116
    COMERCIALIZADORA NUTRECO CHILE LTDA¦KORI 5 KORI -LOTE: 3470059-FECHA DE ELABORACION: 11-05-2017...........¦123650
    COMPANIA SIDERURGICA HUACHIPATO S..¦BARRAS DE ACERO DE ACERO PARA USO EN LA INDUSTRIA METALURGICA BARRA DE¦204155
    EXPORTADORA EL REFUGIO LTDA........¦MANZANA LUCKY MANZANAS FRESCAS PARA CONSUMO HUMANO CAJAS DE CARTON CON¦21300
    EXPORTADORA EL REFUGIO LTDA........¦MANZANA LUCKY MANZANAS FRESCAS PARA CONSUMO HUMANO CAJAS DE CARTON CON¦21300
    LAMINADORA LOS ANGELES SA..........¦MADERA ASERRADA PINUS RADIATA PARA USO COMERCIAL MADERA ASERRADA SECA.¦109409
    MADERAS IMPREGNADAS PRESERVA LTDA..¦POSTE DE PINO 2 - 3 X 2.40 MTS                                 ¦51087
    MONO AZUL SOCIEDAD ANONIMA.........¦PERAS FRESCAS MO¥O AZUL GRADO: ELEGIDO CALIBRE: 165 ATM: CC COMERCIALI¦25360
    MONO AZUL SOCIEDAD ANONIMA.........¦PERAS FRESCAS MO¥O AZUL GRADO: ELEGIDO CALIBRE: 150 ATM: CC COMERCIALI¦25200
    PRIMAR SA..........................¦ALIMENTO PARA PECES PRIMAR -PROTEC 1 PR-LOTE: 3441119.................¦51000
    PRIMAR SA..........................¦ALIMENTO PARA PECES SKRETTING LOTE: 3456065 EN BOLSAS DE 20KG PROTEC 5¦25500

    IMPORTACIONES CALLAO: EXPORTADORES
    FECHA: 28 MAYO 2017(CALLAO)
    BUQUE: BBC NEBRASKA


    ORIGEN..¦EXPORTADOR..........¦PRODUCTO..............................................................¦KILOS
    ANTWERPEN
    NLMK PLATE SALES...................¦PLANCHAS -PLANCHAS DE ACERO RODADAS A CALIENTE 12 PZAS-ESPESOR: 6.5 AN¦496102
    GALVESTON
    ORICA INTERNATIONAL PTE LTD........¦DETONADORES ELECTRONICOS ORICA DPIRXII.15CZSLA USO EN MINERIA ELECTRON¦21445
    HOUSTON
    BRIDGEWELL RESOURCES...............¦POSTES DE MADERA TRATADA TRATADOS CON CCA 0.8 LIBRAS X PIE CUBICO PARA¦29313
    BRIDGEWELL RESOURCES LLC...........¦POSTES DE MADERA TRATADA TRATADOS CON CCA 0.8 LIBRAS X PIE CUBICO PARA¦19672
    COLOMBO MARINE INC.................¦PLANCHAS MEDIDA: 1/2 X 120 X 480 PARA USO INDUSTRIAL PLATE: ASTM SA5¦9261
    CONCANNON LUMBER...................¦POSTES DE PINO: 20 PZS SOUTHERN YELLOW PINE UTILITY POLES CCA TREATED.¦25971
    CPVEN SERVICIOS PETROLEROS SAC.....¦CAJA ALLISON (TRANSMISION) CLT6061-4 SERIES N U86237 / U86252 PARA MAQ¦2561
    GEOD DRILLING EQUIPMENT & SUPPLY...¦KIT DE REPARACION MENOR . . P/N 13304198PARA EQUIPO DE PERFORACION-RIG¦1380
    PACIFIC SERVICES & TRADING INC.....¦ANGULO STEEL ANGLES DE HIERRO O ACERO REF: ASTM A131-A ABS GRA 20 PULG¦12949
    PACIFIC SERVICES & TRADING INC.....¦CUCHARON CATERPILLAR BUCKET 374 S/N 302-8995 BUCKET-XD 83" 6.00 YD3 (E¦12020
    PACIFIC SERVICES & TRADING INC.....¦797F BODY PO: CG00394A SERIAL NUMBER: MAJ00776 INV: 01G 132351........¦43477
    PLUSPETROL INTERNATIONAL INC.......¦ACEITE LUBRICANTE FRICK 5 TAMBORES CON 55 GALONES CADA UNO ACEITE LUBR¦1179
    PLUSPETROL INTERNATIONAL INC.......¦INHIBIDOR DE CORROSION BECOR CORROSION INHIBITOR BECORIN 1000 LT POR T¦46239
    SCHLUMBERGER TECHNOLOGY CORPORATION¦ADITIVO DE FRACTURACION SCHLUMBERGER LOTE : HO16125999 USO EN LA INDUS¦4595
    MOBILE
    BRIDGWELL RESOURCES LLC............¦POSTE DE PINOS 4/50 CERTIFICADO FITOSANITARIO N F-F-01097-06420501-7-B¦76089
    TAMPICO
    EXPLOSIVOS MEXICANOS SA DE CV......¦EXPLOSIVO PARA VOLADURA DE CONTORNO SENATEL MEZCLA BASE DE NITRATO DE.¦160595

    IMPORTACIONES CALLAO: EXPORTADORES
    FECHA: 28 MAYO 2017(CALLAO)
    BUQUE: BOCHEM LUXEMBOURG


    ORIGEN..¦EXPORTADOR..........¦PRODUCTO..............................................................¦KILOS
    POINT LISAS
    MATHANEX TRINIDAD TITAN UNLIMITED B¦METHANOL ALCOHOL METILICO. METHANOL COMERCIALIZADO POR TONELADAS......¦300000
    MATHANEX TRINIDAD TITAN UNLIMITED B¦METANOL COMERCIALIZADO POR TONELADAS USO..............................¦1000000

    IMPORTACIONES CALLAO: EXPORTADORES
    FECHA: 28 MAYO 2017(CALLAO)
    BUQUE: JADE


    ORIGEN..¦EXPORTADOR..........¦PRODUCTO..............................................................¦KILOS
    DESTREHAN
    BUNGE LATIN AMERICA LLC............¦MAIZ AMARILLO COMERCIAL GRANEL LOADED 21226.409 MT OF US NO. OR BETTER¦21226409
    BUNGE LATIN AMERICA LLC............¦MAIZ AMARILLO COMERCIAL GRANEL LOADED 21226.408 MT OF US NO. 2 OR BETT¦21226408
    BUNGE LATIN AMERICA LLC............¦FREJOL DE SOYA COMERCIAL GRANEL LEADED 5499.796 MT OF U.S. NO. 2 BETTE¦5499796

    IMPORTACIONES CALLAO: EXPORTADORES
    FECHA: 28 MAYO 2017()
    BUQUE: JUSTICE EXPRESS


    ORIGEN..¦EXPORTADOR..........¦PRODUCTO..............................................................¦KILOS
    BAYTOWN
    KOCH SUPPLY AND TRADING LP.........¦ULTRA LOW SULFUR DIESEL (ULSD) COMBUSTIBLE PARA EMBARCACIONES AUTOMOTO¦12016387
    KOCH SUPPLY AND TRADING LP.........¦ULTRA LOW SULFUR DIESEL -ULSD- IN BULK................................¦29167409

    IMPORTACIONES CALLAO: EXPORTADORES
    FECHA: 28 MAYO 2017(CALLAO)
    BUQUE: SEABOARD AMERICA


    ORIGEN..¦EXPORTADOR..........¦PRODUCTO..............................................................¦KILOS
    BROOKLYN
    INTERNATIONAL WIRE GROUP...........¦RECORTERIA DE COBRE COPPER SCRAP RECORTERIA DE COBRE (SCRAP DE HILO DE¦16187
    TOYOTA TSUSHO AMERICA INC..........¦ANTICONGELANTE ; TOYOTA ; NRO AUTOPARTE:D0888-980039 CLNT C451 10451/5¦9792
    GUAYAQUIL
    CITIKOLD SA........................¦CONTENEDORES VACIOS...................................................¦0
    CITIKOLD SACITIKOLD SACITIKOLD SACI¦CONTENEDORES VACIOS...................................................¦0
    MIQ GLOBAL LLC.....................¦SUMINSTRO PARA MINERIA................................................¦11308
    MIQ LOGISTICS LLC..................¦POSTES DE MADERA......................................................¦27433
    HOUSTON
    AGILITY PROJECT LOGISTICS INC......¦ACEITES LUBRICANTES CHEVRON CHEVRON ACEITES LUBRICANTES CHV DELO TORQF¦134030
    AGILITY PROJECT LOGISTICS INC......¦ACEITES LUBRICANTES CHEVRON ACEITE LUBRICANTE CHV DELO TORQFORCE SAE 1¦115570
    AMEROPA NORTH AMERICA INC..........¦ARROZ EL PLEBEYO COMERCIAL/CONSUMO HUMANO BULTOS US NO.2 OR BETTER LON¦260147
    BECKER CUSTOM TRAILERS.............¦O3 CARRY ON TRAILER SPGSM A¥O FAB:2017 A¥O MOD:2017 CA:OTROS USOS ESPE¦3924
    BOSTON AGREX INC...................¦HIGADO DE RES IBP PARA LA INDUSTRIA DEL EMBUTIDO USO:.. HIGADO DE VACU¦26681
    BOSTON AGREX INC...................¦HIGADO VACUNO HIGADO DE BOVINO USO: COMERCIALIZACION FROZEN BEEF LIVER¦26281
    BRENNTAG LATIN AMERICA INC.........¦EPIKURE CURING AGENT 3290 EPIKURE USO INDUSTRIAL PRESENTADO EN 1 TAMBO¦13325
    CHANNEL PRIME ALLIANCE.............¦COPOLIMERO DE ETILENO ENABLE 20-10HE ENABLE 20-10HE COPOLIMERO DE ETIL¦50428
    CHEMTEX INTERNATIONAL..............¦COPOLIMERO CHEMTEX -COPOLIMERO DE ALTA DENSIDAD RESINA PLASTICA SINTET¦94145
    CHEMTEX INTERNATIONAL..............¦HOMOPOLIMERO CODIGO: CH00760 HIGH DENSITY HOMOPOLYMER.................¦150952
    CHEVRON PRODUCTS CO................¦ACEITE BASE PARA LUBRICANTE CHEVRON 246747 ACEITE BASE CHV NEUTRAL OIL¦20412
    CORPAC STEEL PRODUCTS CORP.........¦TUBOS ITEM CODE: CWSP008X0322DH2-01 USO EN OLEODUCTOS O GASEODUCTOS EN¦271825
    COVESTRO LLC.......................¦ARCOL POLYOL ARCOL F3040 LOTE: PC87110409 PC87110410 PARA LA PRODUCCIO¦17232
    COVESTRO LLC.......................¦DESMODUR T80 COVESTRO T80 LOTE: PA85002408 UTILIZADO COMO MATERIA PRIM¦21339
    COVESTRO LLC.......................¦DESMODUR T80 COVESTRO T80 LOTE: PA85002408 UTILIZADO COMO MATERIA PRIM¦21339
    COVESTRO LLC.......................¦DESMODUR T80 COVESTRO T80 LOTE: PA85002412 UTILIZADO COMO MATERIA PRIM¦21339
    COVESTRO LLC.......................¦DESMODUR T80 COVESTRO T80 LOTE: PA85002410 UTILIZADO COMO MATERIA PRIM¦21339
    COVESTRO LLC.......................¦DESMODUR T80 COVESTRO T80 LOTE: PA85002412 UTILIZADO COMO MATERIA PRIM¦21339
    COVESTRO LLC.......................¦TOLUENE DI ISOCYANATE DESMODUR DESMODUR T80 TIGHT HEAD DRUM (250 KGS).¦42678
    COVESTRO LLC.......................¦ARCOL POLYOL ARCOL F3040 LOTE N° PC87110410 PARA LA PRODUCCION DE POLI¦17232
    ERGON REFINING INC.................¦MORITE MEJORA LA DISPERSION DE LA MATERIA PRIMAS QUE ENTRA FACILITANDO¦21388
    EXXONMOBIL CHEMICAL CO.............¦RESINA DE POLIETILENO EXCEED3518CB BATCH: 17284 USO: MATERIA PRIMA PAR¦24076
    EXXONMOBIL CHEMICAL CO.............¦COPOLIMERO DE ETILENO EXXON 900 BAG - SMALL BAGS PARA USO INDUSTRIAL L¦71327
    EXXONMOBIL LUBRICANTS TRADING CO...¦MOBILGREASE XHP 681 MOBIL EN 96 TAMBORESDE 180 KILOS PARA USO COMERCIA¦19022
    EXXONMOBIL LUBRICANTS TRADING CO...¦M-1 FS 0W40 MOBIL EN 1560 CAJAS PARA USOCOMERCIAL 112634 M-1 FS 0W40 C¦15913
    EXXONMOBIL LUBRICANTS TRADING CO...¦MOBILTAC 325 NC MOBIL EN 56 TAMBORES USOCOMERCIAL 103867 MOBILTAC 325.¦19084
    EXXONMOBIL LUBRICANTS TRADING CO...¦MOBILTAC 375 MOBIL EN 8 TAMBORES USO COMERCIAL 100691 MOBILTAC 375NC N¦16722
    EXXONMOBIL LUBRICANTS TRADING CO...¦M-GREASE XHP 222 MOBIL EN 96 TAMBORES DE180KG PARA USO COMERCIAL 10602¦19306
    EXXONMOBIL LUBRICANTS TRADING CO...¦MOBILTAC 375 MOBIL EN 12 TAMBORES USO COMERCIAL 100691 MOBILTAC 375NC.¦19898
    EXXONMOBIL LUBRICANTS TRADING CO...¦M-ATF D/M BULK MOBIL A GRANEL USO COMERCIAL 113277 M-ATF D/M BULK ACEI¦18372
    EXXONMOBIL LUBRICANTS TRADING CO...¦M-DEL 1 ESP 5W-40 MOBIL A GRANEL PARA USO COMERCIAL 122264 M-DEL 1 ESP¦19424
    EXXONMOBIL LUBRICANTS TRADING CO...¦M-DEL 1 ESP 5W-40 MOBIL A GRANEL PARA USO COMERCIAL 122264 M-DEL 1 ESP¦19505
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          Comment on Don Easterbrook’s Academic Dishonesty by Angela   
Lol...its sad that all peoole want to do or get paid to do or do for funding is try to debunk scientist that try to get real information out there. I think all the good people should just stop trying to save ingnorant sheeple from themselves. Wh6 would Nasa or any of them lie lol? MONEY..ummm careers..just stupid not to look at data yourself which means not going off retarded peer reviews. .lets see is meat still good for us..according to many institutions for public safety it is. FDA ya why would they lie..monsanto? Nasa? The government lies everyday and they control the scientist...but if nasa wants money they need to pose a problem! How many companies get free money to study climate change? Who gets paid for false data? Grow up!
          Edible Buttterflies for Cupcakes and Cakes - Small White Edible Butterfly - Cupcake and Cake Decoration by SugarRobot   

7.95 USD

*Please read shipping & policies info before you place your order for estimated shipping and delivery times

-You will receive 24 of these beauties. Wing span is approx. 1.75 inches - 2 inches

-Precut and ready to use

-Made of wafer paper (potato starch, vegetable oil, water) and food color. FDA approved print.
Each butterfly has been brushed with a coat of organic vanilla flavoring.

-Edible Butterflies are gorgeous on cupcakes or to use as accents on larger cakes. Use a dab of regular frosting or corn syrup to adhere to most food items and wine glasses / serving dishes. Fold up the wings on either side of the body for a fluttering effect.

-Use within 4 months of receiving them. Store in the packaging they arrive in. Each item is sealed for optimum freshness. Do not refrigerate.


Sugar Robot is the ORIGINAL source for Edible Butterflies - our high quality items are pre-cut, vacuum sealed, and ready to use.



★★★★ All Items are Gluten Free and 100% Vegan ★★★★
Although there are no nuts in the ingredients - Sugar Robot's production facilities are NOT a tree nut free environment


Edible Butterflies © are Copyright protected.....Any persons found in violation will be sentenced to the basement and fed to our Copyright Monster (grrrr) - no really, they are protected


          The Original EDIBLE BUTTERFLIES- small Blue Green - Cake & Cupcake toppers - Food Decorations by SugarRobot   

7.95 USD

*Please read shipping & policies info before you place your order for estimated shipping and delivery times

-These lifelike butterflies are completely edible!

-You will receive 24 of these blue and green beauties. Wing span is approx. 2 inches.

-Precut and ready to use

-Gorgeous on cupcakes or to use as accents on larger cakes. Use a dab of regular frosting or corn syrup to adhere to most food items, wine glasses, or serving dishes.

-Made of wafer paper (potato starch, vegetable oil, water) and food color. FDA approved print.
Each butterfly has been brushed with a coat of vanilla

-Use within 4 months of receiving them. Store in the packaging they arrive in. Each item is vacuum sealed for optimum freshness. Do not refrigerate.


★★★★ All Items are Gluten Free and 100% Vegan ★★★★
Although there are no nuts in the ingredients - Sugar Robot's production facilities are NOT a tree nut free environment.


Edible Butterflies © are Copyright protected.....Any persons found in violation will be sentenced to the basement and fed to our Copyright Monster (grrrr) - no really, they are protected


          Itsy Bitsy Mini Edible Butterflies - Rainbow Assortment set of 48 - for Cake Decorating and Cupcake Toppers by SugarRobot   

10.50 USD

Edible Itsy Bitsy Butterflies are small enough to flutter on a sugar cube or tooth pick! Each super tiny edible butterfly is precision cut and ready to use.

*Please read shipping & policies info before you place your order for estimated shipping and delivery times

-You will receive 48 of these super mini assorted beauties. Wing span is approx. 7/8 of an inch.
**Please note - the toothpicks are not included**

-Made of wafer paper (potato starch, vegetable oil, water) and food color. FDA approved print.
Each butterfly has been brushed with a coat of organic vanilla flavoring.

-Use a dab of regular frosting or corn syrup to adhere to most food items, wine glasses, and serving dishes. Fold up the wings on either side of the body for a fluttering effect.

-Use within 4 months of receiving them. Store in the packaging they arrive in. Each item is sealed for optimum freshness. Do not refrigerate.


Check out the other Itsy Bitsy colors available in our shop:
http://www.etsy.com/shop/SugarRobot?section_id=7402928


★★★★ All Items are Gluten Free and 100% Vegan ★★★★
Although there are no nuts in the ingredients - Sugar Robot's production facilities are NOT a tree nut free environment


Edible Butterflies © are Copyright protected.....Any persons found in violation will be sentenced to the basement and fed to our Copyright Monster (grrrr) - no really, they are protected


          EDIBLE Butterflies The Original - Assorted Blue and Green- set of 30 - Cake & Cupcake toppers - PRECUT and Ready to Use by SugarRobot   

21.95 USD

Sugar Robot is the ORIGINAL source for Edible Butterflies on Etsy - our high quality items are pre-cut, vacuum sealed, and ready to use.

*Please read shipping & policies info before you place your order for estimated shipping and delivery times

-Lifelike butterflies are completely edible!

-You will receive 30 assorted butterflies as shown

-Wing spans vary from 4 inches to 1inch

-Pre-cut and Ready to Use

-Made of wafer paper (potato starch, vegetable oil, water) and food color. FDA approved print. Brushed with organic vanilla

-Use a dab of regular frosting or corn syrup to adhere to most food items, wine glasses, and serving dishes. Fold up the wings on either side of the body for a fluttering effect.

-Use within 4 months of receiving them. Store in the packaging they arrive in. Each item is sealed for optimum freshness. Do not refrigerate.


..ƸӜƷ.. We have this set available in a variety of colors. Mix and match any of the sets available at no additional charge.
https://www.etsy.com/shop/SugarRobot?section_id=6865404

** The cake used in the item photos is a 3 tier wedding cake with a 14 inch base.

★★★★ All Items are Gluten Free and 100% Vegan ★★★★
Although there are no nuts in the ingredients - Sugar Robot's production facilities are NOT a tree nut free environment.


Edible Butterflies © are Copyright protected.....Any persons found in violation will be sentenced to the basement and fed to our Copyright Monster (grrrr) - no really, they are protected


          Regulatory Affairs Associate III, Pre Approval - Teva Pharmaceuticals - Parsippany, NJ   
Interacts with FDA and all Teva sites via written and phone communications. Interpersonal Demonstrates ability to establish sound professional relationships...
From Teva Pharmaceuticals - Fri, 31 Mar 2017 16:03:18 GMT - View all Parsippany, NJ jobs
          FDA clears Varian's Halcyon rad therapy system   

The U.S. Food and Drug Administration (FDA) has cleared radiation oncology...



          Comment on FDA Declared Citi Housing Scheme Faisalabad’s Plots Registration, A Fraud by Waheed   
Always Right
          Top 20 Toxic Products We Give Our Children | Healthy Mind | Alternative Health | Life Enthusiast Podcast | Podcast #232   
itunes pic

The top 20 products more toxic than lead.

Number 20

Shampoo and bath products
Virtually all popular shampoo and bath products sold on the market contain cancer-causing chemicals. The ingredients read like a top-40 list of toxic chemicals. Virtually none of these chemicals have ever been tested or approved for use on humans (they are simply ignored because the FDA astonishingly believes the skin won't absorb chemicals).

Support the health of all systems: use internally and externally. Cleanse, detoxify, deodorize and eliminate pests & parasites on yourself, pets, plants & livestock. Fertilize your plants, gardens and field crops.

By using Miracle II products you will eliminate toxic & caustic chemicals from our environment, while saving hundreds of dollars every year. After this natural soap has finished cleaning, it goes down the drain, continuing to clean up our environment.

Miracle II Liquid Soap contains no synthetic oils, no animal fat, and no preservatives. It is biodegradable and naturally concentrated. Use sparingly, as less is better.

http://life-enthusiast.com/usa/liquid-soap-p-457.html?tab=ingredients

Number 18

Dryer sheets
Most popular dryer sheets and fabric softeners are made with toxic synthetic chemicals that are not safe to use on children's clothing. The fragrance chemicals alone are often highly carcinogenic, and the other chemicals contribute additional toxicity to the clothing.

Children's clothes should never be washed or dried in chemicals. Only use natural detergents and fabric softeners, or avoid the fabric softeners altogether.

Miracle II
Laundry and Bath Ball

The perfect solution for sensitive skin, as your laundry will have no residual irritating detergents, fragrances, or softening agents. Sensitive skin will enjoy bathing with this Laundry Ball in the tub.

Two hundred and nine spikes on the ball are specially designed to gently scrub & massage laundry, as it bobs around in the washing machine. Impregnated with Miracle II MiracleLiquid Soap and Miracle II Neutralizer, the ball will leave your laundry energized, fresh, clean and free of residual chemicals.

http://life-enthusiast.com/usa/laundry-bath-ball-p-451.html

 

Read the entire top 20 list
http://www.naturalnews.com/022014.html


          Stacy Malkan on Not Just a Pretty Face: The Ugly Side of the Beauty Industry   
Last month Rep. Jan Schakowsky (D-IL) introduced legislation that would toughen safety standards for beauty products and require regular government testing for hazardous ingredients. DemocracyNow! hosted a debate between Stacy Malkan, founder of the Campaign for Safe Cosmetics and author of Not Just a Pretty Face: The Ugly Side of the Beauty Industry, and John Bailey, chief scientist at the Personal Care Products Council and a spokesperson for the cosmetics industry. We feature some excerpts from Stacy Malkan's comments:

I actually was a lover of makeup when I was a teenager. I used lots of products. And I was using about twenty products a day. So that was shampoos, lotions, hair gels, all kinds of makeup. And for the book, I went back, and I actually looked up all of those products that I had been using as a teen and learned that I had been exposing myself to 230 synthetic chemicals every day, you know, before even getting on the school bus. And that’s pretty typical kind of exposures for a teenage girl.

So, in that mix were seventeen carcinogens, chemicals linked to cancer. There were dozens of hormone-disrupting chemicals, many parabens, which can act like estrogen in the body. Lots of these products, as we know from the product tests we’ve conducted at Campaign for Safe Cosmetics, are contaminated with carcinogens like formaldehyde and 1,4-dioxane, that are not listed on the label. We found those chemicals in dozens of top-selling children’s bath products.

There are two huge loopholes in labeling laws. The companies don’t have to tell us what’s in fragrance, and that can be a dozen or more chemicals that are in any shampoo or conditioner with a fragrance, for example. They also don’t have to tell us about contaminants or byproducts, and those are some common ones that typically get into products from the chemical processes that are used. So, formaldehyde, 1,4-dioxane would be examples, nitrosamines. Those are carcinogens. We find lead in lipstick. We’ve done tests of kids’ face paint and found low levels of lead, as well as other heavy metals like nickel and chromium.

So, contaminants are very common. The industry knows about them. FDA knows about them. But there are no limits. And the only way to find out if your product contains them is to send it to a lab and spend a couple of hundred dollars to test it.

So the problem with cosmetics, as I was saying about my own daily exposures, it’s the mixture of low levels of hazardous chemicals that we’re exposed to continually, day after day after day. And the companies always say, and I’m sure John will say, it’s just low levels, it’s just a little bit, just traces of1,4-dioxane and formaldehyde. But, you know, these are chemicals derived from oil products with known toxicities, and they’re mixed together. So a typical baby in a tub could be exposed to formaldehyde and 1,4-dioxane from the shampoo, the bubble bath, the body wash. The same chemicals are used in laundry detergent, dish soap. So the exposures are continual. And there’s no need for it. There’s absolutely no reason on earth for baby shampoos to contain carcinogens. The companies already know how to make products without those chemicals, and that’s what they should be doing.
- Stacy Malkan from DemocracyNow!.
          Are Raw Cherries a Drug? | Alternative Health | Life Enthusiast Podcast - Podcast #156   
As Americans struggle to eat a healthier diet, the FDA has taken draconian steps to suppress information about foods that reduce disease risk. While various agencies of the federal government encourage us to eat more fruits and vegetables, the FDA has issued an edict that precludes cherry companies from posting scientific data on their websites. This censorship of published peer-reviewed studies denies consumers access to information that could be used to make wiser food choices. ( Read More.) All this and more in today's podcast. Each week Martin Pytela and Scott Paton discuss Holistic principles for healthy living. Life Enthusiast Co-op is built on over 25 years in study, health consultations and market research in the field of holistic and alternative medicine. We deliver solid time tested expertise. We are in this business not for the money, but for the passion, we have for sharing with others what we had to learn the hard way, through experience. We focus on high quality, innovative holistic solutions. Length: 25:27 Go to iTunes and review our podcast: iTunes Life Enthusiast Reviews and 5 star ratings <><><><><><><><><><><><><><><><><><><><><><><><><>
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          Shkreli Trial Weekend One Ruminations... How "Fast" Fred Hassan And Mr. Shkreli Differ -- But Do "Echo" One Another...   

[Forgive me, as this is a long read. So go grab a cuppa... and return. Note: oddly, I didn't need to photoshop Mr. Shkreli's face at all(!); but I did do so, in 2010, as to Mr. Hassan, at right.] Billy and I were discussing, at least a bit -- in comments yesterday how... ironic if you will -- it was that Mr. Hassan was testifying for the government, against Mr. Shkreli.

At the outset, let me be clear: I absolutely think Mr. Hassan told the truth, yesterday -- on the stand. Without exception. As Billy pointed out -- he has absolutely zero motive to lie: it gains him... nothing. He was simply backing up the truth of what his own daughter told him, and he saw, in some cases, first hand. [Mr. Brafman shouldn't have opened the door on Thursday, to his appearance, as a surprise rebuttal witness. But I digress.]

In any event, I surmise that in Mr. Hassan's eyes, Mr. Shkreli is an insignificant wanna-be -- who tried to "draft" -- and deceptively, so -- off of Mr. Hassan's Tour du France run, in and through pharma, and later, life sciences private equity.... [but Mr. Hassan has enough "London School" in him, to feign humility on the stand, and still destroy Mr. Shkreli -- in icily civil tones, anyway]. Pure upper crust.

As one final side note, before I get to my main narrative thrust -- it is interesting that the pool reporter, in court in Brooklyn, when Mr. Hassan took the stand didn't tweet any of his direct testimony -- only the cross, and redirect. It is interesting because Mr. Hassan works as a color analyst for that same reporter's network from time to time. [I still wonder -- what, exactly did he testify about, on direct? Besides saying his daughter told the truth on Thursday afternoon.]

Now -- to the main point: As Billy well knows, and anyone who followed my life sciences blog in the early days, now almost ten years ago, well-knows: Mr. Hassan is an ironic figure here, because according to hundreds of thousands of pages of federal court filed civil documents in the US District Courts, for the Districts of New Jersey and New York's Southern District (Manhattan) -- among others, he is a velvet gloved version of Mr. Shkreli's price gouging strategems.

But he is an Augusta National Golf Club (white gloved) version of Mr. Shkreli's street ball, at the public Rucker Park concrete courts -- in NYC. [See any old AndOne Rucker tournament (early 2000s) YouTube for the reference; not that Mr. Shkreli could ever hoop, mind you -- nor Mr. Hassan... golf, but you get the gist of the notion.] Mr. Hassan has had his own sketchy encounters... with securities fraud and drug price gouging allegations.

That is, in my opinion, Mr. Hassan (using white gloves, by having "his people" do the dirty work), effectively delayed releasing the ENHANCE clinical trial (null outcome) results on Vytorin®, all while Schering-Plough raked in billions -- literally billions of dollars (often at $320 per bottle, compared to about $32, for the generic statin) -- over five years, minimum (2003 to 2009), for a hideously expensive... placebo [that according to Senator Chuck Grassley, R, IA]. Of course, it is now generic. And in 2016, IMPROVE-IT saw a very modest CV improvement for the med-combo, though it would take seven years of drugging 1,000 people every day, to see one fewer CV event. Ahh... but that was the last war -- not this one.

Mr. Brafman did ask Mr. Hassan -- about the Vytorin affair, on cross -- but we do not know what he asked, or how Mr. Hassan answered. [Pool reporters were... silent, on the substance of those Q&As. We do know they grew "heated", according to pool reporters.] I can be certain that Mr. Hassan told the truth, on cross: as all those federal civil securities fraud class actions, and reimbursement fraud matters were... settled, long ago. But one (just one of many) settled for more than a half-billion dollar payout from Schering-Plough, and its D&O insurers. Mr. Hassan's insurer(s), to put a point on it.

Now -- Mr. Hassan did it (in my opinion), in the "polite" way. Politely, through clenched teeth, and steely smiles -- more like grimaces. That is, he never made an affirmatively boldly false statement -- other than that the Wall Street Journal and the FDA were both being unfair to him (and intentionally trying to keep his drugs off-market), of course (ironic, that, given yesterday's circus in the press room -- with Mr. Shkreli holding court, about the evil press)...

Mr. Shkreli on the other hand, openly told people he was jacking up the price of an old generic AIDS drug -- just because he could. To be clear, that is not what he's on trial for though. He's on trial for openly lying to investors, and committing fraud, in the manipulation of the public securities markets. And for "parking" shares. [Lots more on that, in the coming weeks -- as to Count Eight. Stay tuned.] But if Mr. Hassan were going to protect his own skin (on cross), he would have wanted to create cover for a fellow fraudster. But I honestly think Mr. Hassan thinks he is Mr. Shkreli's "better". He isn't -- not in any way that really matters.

I do think Mr. Shkreli is guilty, on all counts -- and I am entitled to air that bias, now that the jury has been ordered not to read any outside media. But I do not think what Mr. Hassan did in the early part of the 2000s -- at Schering-Plough, and then at Bausch + Lomb, is really different in kind. Only degree -- it is only a more finessed approach to the markets -- one his companies paid vast civil monetary damages for, but he personally did not ever face criminal charges.

Mr. Shkreli richly deserves his fate. But I did nearly gag, when the pool reporter called Mr. Hassan a "legend" [a reporter from the network where Mr. Hassan is a an occasional talking head] in the pharmaceutical world.... I suppose there are dark legends as well as light ones. And no person is all good -- or all evil. Each of these men is a oddly complex mix of... both. Mr. Shkreli the more brazen of them, to be sure -- but both have always been infected with a pathological level of greed, in my opinion. They are different by degree (and pedigree), not kind, in my view. [And candidly I too (to many may appear to be -- scratch that -- am) one of the guilty one percenters, so this all may seem rather hypocritical -- but I do try to add value to any situation I enter . Truly, I do mightily try to leave it better than I found it, for all.] But I do not always achieve that, in deal-craft. So it goes.

So I'll close thus -- maybe the assigned pool reporter for Friday morning didn't want (or was instructed by downtown not) to tweet out any of the above -- potentially tarnishing the network's vaunted color commentary analyst, on matters life sciences. That's just a guess. You decide for yourselves -- whatever it is you choose to believe.

Have a freedom-laced Fourth, one and all -- and do try to ignore Agent Orange, altogether. Likely silent here, until the Fifth, at 9 AM EDT when trial resumes.

नमस्ते
          FDA accepts application for Salix Pharmaceuticals' new bowel cleansing preparation — 4 key notes   

          FDA tightens rules on putting antibiotics in livestock feed and water   
A federal regulation that took effect Jan. 1 will only allow livestock feed and water laced with antibiotics to be used only under a veterinarian’s supervision.
          Clinical Research Nurse - Mid-Atlantic Permanente Medical Group - Largo, MD   
Investigator CVs, financial disclosure forms, laboratory certifications, radiation safety exemptions, FDA 1572 forms, etc....
From Mid-Atlantic Permanente Medical Group - Wed, 22 Mar 2017 10:28:47 GMT - View all Largo, MD jobs
          Program Coordinator, FDA and Third Party Tobacco Retail Inspection Program - JBS International, Inc. - Maryland   
Experience in conducting data analysis, preferably using SQL server databases. A Bachelor's degree, in business administration, public administration, criminal...
From JBS International, Inc. - Fri, 02 Jun 2017 03:23:28 GMT - View all Maryland jobs
          KPSC SDA FDA Result 2017 kpsc.kar.nic.in Cut Off Marks Merit List   
KPSC SDA FDA Result 2017 Dear examinees, kindly read this information to check KPSC SDA FDA Result 2017 online here. Karnataka Public Service Commission had conducted an examination for the First Division Assistant and Second Division Assistant posts in February 2017. The Result evaluation process is in the final stage now. The authority is supposedly […]
          DEADSTOCK K-Swiss X Billy Reid Arlington White Shoes 03422-152   
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A love affair of classic American style, K-Swiss partners with CFDA Designer of the Year Award winner Billy Reid to reintroduce the fashion designer’s longtime favorite heritage sneaker, the Arlington K-Swiss X Billy Reid Collection Lace up with metal D rings Premium leather upper Iconic 5 striped on side Leather heel tab Cushioned insoles Material: Premium leather upper Rubber sole  


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A love affair of classic American style, K-Swiss partners with CFDA Designer of the Year Award winner Billy Reid to reintroduce the fashion designer’s longtime favorite heritage sneaker, the Arlington K-Swiss X Billy Reid Collection Lace up with metal D rings Premium nubuck upper Iconic 5 striped on side Leather heel tab Cushioned insoles Material: Premium nubuck upper Rubber sole  


          Clinical Research Nurse - Mid-Atlantic Permanente Medical Group - Largo, MD   
Investigator CVs, financial disclosure forms, laboratory certifications, radiation safety exemptions, FDA 1572 forms, etc....
From Mid-Atlantic Permanente Medical Group - Wed, 22 Mar 2017 10:28:47 GMT - View all Largo, MD jobs
          Program Coordinator, FDA and Third Party Tobacco Retail Inspection Program - JBS International, Inc. - Maryland   
Experience in conducting data analysis, preferably using SQL server databases. A Bachelor's degree, in business administration, public administration, criminal...
From JBS International, Inc. - Fri, 02 Jun 2017 03:23:28 GMT - View all Maryland jobs
          Intellipharmaceutics Announces FDA Advisory Committee Meeting for Rexista™ (oxycodone hydrochloride extended release), an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain   
Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:IPCI) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration ("FDA") has been scheduled for July 26, 2017 to review the Company's New Drug Application ("NDA") for RexistaTM abuse-deterrent oxycodone hydrochloride extended release tablets. 
          Regulatory Affairs Associate III, Pre Approval - Teva Pharmaceuticals - Parsippany, NJ   
Interacts with FDA and all Teva sites via written and phone communications. Interpersonal Demonstrates ability to establish sound professional relationships...
From Teva Pharmaceuticals - Fri, 31 Mar 2017 16:03:18 GMT - View all Parsippany, NJ jobs
          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          Comment on CBT 14 Era Bookmark by azithromycinCrync   
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          Mid Year 2017 Portfolio Review   
My portfolio is up 15.75% for the first six months of 2017, pulling up my since inception IRR to 23.74%, and comfortably ahead of the S&P 500's 9.34% gain so far this year.  Significant winners have been Tropicana Entertainment, MMA Capital, Pinnacle Entertainment and Resource Capital, the only significant loser has been New York REIT.
Closed Positions:
  • ILG Inc (ILG): In hindsight, this was one of my favorite special situations of the past several years.  ILG (f/k/a Interval Leisure Group) had entered into a reverse morris trust transaction with Starwood prior to the announcement of Starwood's merger with Marriott, thus those that wanted to play the merger arb on the Starwood/Marriott transaction had to short out both Marriott and ILG against Starwood creating an uneconomic selling pressure on ILG's shares.  Since the deal has closed, ILG has run up well over 100%, I unfortunately sold a little too soon in the low $20s as ILG is now being bid up under speculation of a merger with Marriott Vacations Worldwide (VAC).  I'll be looking closely for ideas like this in the future, something similar was the Dell buyout of EMC/VMWare which created a coiled spring in VMWare stock that's caused the DVMT tracker to do very well too.
  • Actelion (ALIOY):  The Actelion/J&J deal closed and the development stage biotech company that was created out of the merger, Idorsia, has done very well too.  I bought the unsponsored ADR, there was a short week or two there when the shares dropped and people started speculating on why and if withholding taxes were going to be an issue, I got scared out of my position, ended up making a small amount of money but left some on the table.
  • CSRA (CSRA):  CSRA is the government services spinoff of CSC, with CSC I had the right idea at the time of the spinoff, CSC was setup to be sold and it was earlier this year when it merged with a division of HP Enterprises in a reverse morris trust to create DXC Technology (DXC).  I haven't spent much time on DXC, but CSC turned out to be the better side of the CSC/CSRA split.   I ended up selling CSRA earlier this spring in a slight fit as I didn't realize pension income was being included in their "adjusted" EBITDA figure they were presenting.  It caused the shares to look artificially cheap compared to peers and I just missed it, lesson learned.
  • WMIH Corp (WMIH):  The white whale of NOL shells, with over $6B in NOLs and apparently no dance partner in sight, it appears like the company's sponsor KKR is unable to find a deal that makes sense, they can walk in January, and will likely use that as leverage to strike an even more advantageous deal with WMIH.  If a deal does happen in the meantime, there still could be money to be made after but I don't see a reason to wait around any longer.
Previously Unmentioned New Positions:
  • Miramar Labs (MRLB):  Miramar Labs is another CVR opportunity, and even smaller than the others mentioned on the blog, but they make a medical device that's used to reduce underarm sweat and hair.  It's more of a elective beauty and/or lifestyle product that is sold to plastic surgeons, spas, etc, and its treatments are paid in cash and not processed through insurance companies.  Sientra (SIEN) is buying Miramar for $0.3149 per share upfront and $0.7058 per share in contingent payments for a total just over $1.02 per share.  The contingent payments are a little unique, where the milestone is a cumulative net sales number with no deadline.  Unlike the other CVRs that rely on an FDA approval, here Miramar already has an approved and commercialized product, so unless the sales flop going forward, the payout should occur, its just a matter of when.  The big payout is for $80MM in sales, Mirmar did $20MM in sales last year, but they're seeing some growth, I'm modeling out a 3-3.5 year timeframe to hit the milestone payment which at current prices of around $0.55 per share generates a pretty nice IRR.  Thanks to @yolocapital on Twitter for pointing it out to me.
  • Sound Banking Company (SNBN):  Sound Bank is a tiny North Carolina based community bank that is being acquired by another small bank but with high growth ambitions, West Town Bancorp (WTWB).  There are many small bank mergers happening, if I was less capital constrained, or had a lower risk mandate I'd probably be diving head first into more of these as the spreads are fairly wide for what should be low risk deals.  West Town Bancorp is offering $12.75 in cash or 0.6 shares of WTWB for each share of SNBN.  With SNBN currently trading at $13.40, you could create shares of WTWB for $22.33 when they currently trade for $24.45.  There is a cap on the cash/stock consideration, so proration is likely with the stock trading over the $12.75 cash payout, but it still seems/seemed like a good bet, the merger is expected to close in the third quarter.
  • Interoil Corp (IOC) Contingent Resource Payment:  I got bored and ended up trying this CRP/CVR the day or two before the merger with Exxon Mobil was completed, no view on how much natural gas is actually in PNG, so its a pure speculation that should be decided in the next quarter.
Current Holdings:
I added a little money earlier this year, the performance figures take that properly into account.

Disclosure: Table above is my blog/hobby portfolio, its a taxable account, and a relatively small slice of my overall asset allocation which follows a more diversified low-cost index approach.  The use of margin debt/options/concentration doesn't represent my true risk tolerance.

          Prolift Transvaginal Mesh Introduced Without FDA Pre-Market Clearance: Report   
Washington, DC: Expert insight from a witness in a recent transvaginal mesh lawsuit provides a revealing look into how some products reach the market prior to evolving to become a thorn in the side (or elsewhere) for a patient having undergone a surgical procedure in good faith with a device presumed to be safe
          Canadians Miffed at Failed Physiomesh Approved Under FDA 510(k) Clearance   
Toronto, ON: Colleen Copland feels that she is far too young, at age 34, to be dealing with surgical mesh side effects stemming from an implantation of the now-recalled Ethicon Physiomesh. A routine procedure to repair an abdominal hernia mushroomed into a nightmare for the Canadian woman, who along with one other sufferer interviewed by CTV News (03/28/17) back in the spring have joined a class action surgical mesh lawsuit in Canada
          Expanded Function Dental Auxilary   
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          FDA extends deadline for menu-labeling comments   
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          Dəhşət : Xırdalanda 6 yaşlı uşağa təcavüz etmək istəyən manyak sakinlər tərəfindən tutuldu – Şok Video   
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          Biosimilar Notice May Be Given Prior to FDA Approval   
In a unanimous decision, the Supreme Court of the United States explained that under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), biosimilar makers do not have to wait for approval before giving 180-day notice of commercial...
By: McDermott Will & Emery
          FDA Approved Thyro-Tabs for Dogs With Hypothyroid   

Until recently, there were a variety of levothyroxine medications on the market for dogs with hypothyroidism. The U.S. Food and Drug Administration issued warning letters to 6 manufacturers of unapproved levothyroxine products, which had not been reviewed for safety and … Continue reading

The post FDA Approved Thyro-Tabs for Dogs With Hypothyroid appeared first on VetRxDirect Blog.


          Russian Athletes Doped with Vladimir Putin’s Urine   

putin pissIn light of the recently discovered widespread doping of Russian athletes, international organisations have taken and analysed blood samples taken from Russia’s 2012 Olympic Games participants. After intensive observation and testing, the FDA has confirmed that these individuals show all the hallmarks of one of sporting’s most potent performance-enhancing drugs; The urine of Vladimir Putin. […]

The post Russian Athletes Doped with Vladimir Putin’s Urine appeared first on Oxygen.ie.


          Sculpted   

Oribe Hair Care was behind the scenes at more than a dozen shows during New York Fashion Week Spring/Summer 2016. Here, we give you a sneak peek of the on-trend looks to try this spring.

This season, our lead hairstylists used an abundance of Oribe products to achieve an asymmetrical, sculpted-back style for the CADET show. The look, which was worn by both men and women on the runway, was glossy and polished to perfection. Scroll through the slideshow above and read below to get the looks.

Cadet
Hair by Nathan Nguyen

2015 CFDA nominees Brad Schmidt and Raul Arevalo of Cadet stayed true to their military menswear roots for their first women’s collection at NYFW Spring/Summer 2016. The design duo debuted a modern interpretation of ’40’s World War 2-inspired pieces in a muted palette of black and khaki. Lead hairstylist Nathan Nguyen for Oribe Hair Care created a sleek look that was sculpted close to the head on one side and offset with a deep side part on the other to complement the clothes. “I kept in mind the idea of balancing the masculine and feminine,” said Nguyen of the hair. “I wanted the girls to look confident and modern.”

  1. Prep the hair by spraying Foundation Mist from roots to ends. Follow with Crème for Style, keeping the application light.
  2. Create a deep side part so the hair falls over the right eye. Apply a generous amount of Sculpting Cream to slick back the left side. Use a comb to sculpt the right side of the hair so it curves over the eyebrow and tuck it behind the ear. Pin both sides down in place.
  3. Spray Shine Light Reflecting Spray from midshaft to ends and flatiron section by section.
  4. Finish by spraying Dry Texturizing Spray throughout the length of the hair to create a little lived-in texture.

          Pamela Love   
New York Fashion Week may be over, but that didn't stop us from going to a few of our favorite designers for more inspiration. Since launching her namesake brand in her Brooklyn apartment in 2007, jewelry designer Pamela Love has won a coveted CFDA Swarovski Award for Accessory Design and collaborated with esteemed fashion brands like Zac Posen and Opening Ceremony. Love’s immediately recognizable pieces have become a staple for style savants and an editor favorite. We asked Love to share how she got her start in design, what inspires her and which Oribe products she can't live without.

How did you get your start as jewelry designer?


I studied experimental film and art direction at NYU. After I graduated, I worked as an art director and painting assistant. My background in cinema and the arts inspired me to create jewelry.

How would you describe the Pamela Love girl (or guy)?


Adventurous, romantic, independent and spirited

You mentioned jewelry design wasn't your original path—you received your BFA in Experimental Film and Art Direction from NYU Tisch, as well as working for renowned painter Francesco Clemente. Which three films are a must-see?


If I had to choose, I’d say Holy Mountain, El Topo and Brasil.

Do you have a go-to hairstyle? What are your favorite Oribe products?


I like to keep my hair natural and beachy. My favorite Oribe products are the entire Dry family (Thick Dry Finishing Spray, Dry Texturizing Spray and Soft Dry Conditioner Spray), Intense Conditioner for Moisture and Control, Rough Luxury Molding Wax, Après Beach Wave and Shine Spray and the Signature Conditioner.

If you were to create a piece of jewelry for a salon, what would you create and why?


A hairpiece—something tough, yet feminine.

If you owned a salon, what would it be called?


Love Shack

Your jewelry has a cult following among the fashion elite. What tips do you have for aspiring designers?


Always trust your instincts—don’t just follow the trends.

What inspired your collection for Spring/Summer 2015?


Jewels that take you to the farthest corners of the universe
          Misha Nonoo and Tali Lennox   
Hair by Joey George

Every year, the CFDA and Vogue select a group of emerging designers to participate in the Fashion Fund: a competition where the winner receives a grant to fund their growing business, a design collaboration with a major retailer and mentorships with industry leaders. Misha Nonoo was one of the 10 finalists from this year’s competition, and we were lucky enough to work with her during her journey. Throughout the process, the designers are given challenges to complete by the Fashion Fund panel, including a design challenge. We were with Misha and her model muse Tali Lennox as they prepared to present Misha’s Uniqlo design challenge garment to the judges at a special dinner at Anna Wintour’s home on October 15th. Stylist Joey George created a sleek chignon to complement the trench coat design worn by Tali and gave Misha a simple blowout for the evening.


Get Tali Lennox’s Look:
1. Prep dry hair with Foundation Mist. Apply Maximista to hair section by section from roots to ends, then blow dry.
2. Gather the hair into a low ponytail using Superfine Hair Spray to tame flyaways.
3. Apply Crème for Style to the ponytail and twist into a chignon, securing with bobby pins.
4. Take a small amount of Original Pomade and rub between hands before smoothing over baby hairs around the face and at the nape of the neck.

Get Misha Nonoo’s look:
1. Prep dry hair with Foundation Mist. Apply Maximista to hair section by section from roots to ends.
2. Use a medium round brush and blow out the hair in sections, over-directing at the root for lift.

To learn more about Misha Nonoo, click here.

          Koi   
Koi Suwannagate (pronounced Soo-wahn-na-gate) is a Bangkok-bred fashion designer with a taste for feminine, one-of-a-kind designs. Since launching her brand more than 10 years ago in Los Angeles, Koi has established a signature style of intricate draping and artistic details, been recognized by major fashion industry figures such as Vogue and the CFDA and has received many accolades, including being chosen as one of Women’s Wear Daily’s top 10 collections for Spring/Summer 2009. After a great amount of success, including worldwide distribution to stores like Barneys New York and Nordstrom, as well as a knit collection for Anthropologie, Koi took a break to reassess the direction of her brand. Now she’s back, living in NYC and excited to discuss her future projects as well as what she has learned about the fashion business from her time in the industry.

Did you always know you wanted to be a designer?


No, I didn’t know what I wanted to be until I was 27 years old. But I’ve always liked drawing, especially on the exterior walls of my grandparents’ house, and have been making things with my hands since I was a young girl.

What is your favorite part about being a designer?


I like to be creative and hands-on. When I’m designing, I like to play with texture, color and different design motifs.

You launched your line in 2001 in Los Angeles. What we’re some of the early challenges you faced? What about early wins? What were the really exciting moments for you?


I was one lucky duck! When I started designing, I was still in fashion school and wasn’t really following what was considered in or out of fashion. The idea for my first collection came to me at the last minute when I was turning in a homework assignment. We were asked to decorate t-shirts or something like that. I had painted my shirt, but felt that it needed more design. So, I decided to cut the sleeves into thin strips and tie little bows all around the armhole. I also cut strips on the sides and tied them into notches. When I was finished, many of my friends asked if they could buy the shirt from me. That was my early win, I guess. I then made a small capsule collection with the same idea. The whole collection was bought by a high-end boutique in San Francisco and re-ordered two weeks later. I was overjoyed! They said the idea was quite fresh. Then everything else started happening very quickly.

How would you describe the Koi Suwannagate woman? What is her style?


She is into her own choices. She’s different and she does not follow fashion. She prefers things that are timeless, handmade and exclusive. But, she also likes things that are a bit modern in that she likes things to be incomplete and interesting-looking. She’s not afraid to be different.

Where do you find inspiration for your designs?


Women…I love the female body. I design by draping fabric instead of sketching. I like that my designs evolve throughout the process, and I never know what I’ll end up with. I also love vintage clothing and trims.

In 2007, you debuted your collection at New York Fashion Week to high acclaim from fashion press and retailers. How did you feel showing you’re your designs on such a huge platform? What was it like to receive such high praise following your debut?


It was definitely a great opportunity for me to learn how other designers work and, in general, how the fashion industry works. Before then, I was operating in a vacuum. I learned so much from the experience and got to appreciate all the production that was put together to support the clothing image. It was so unexpected when we learned we were one of WWD’s top 10 collections for that season. It was really a great honor and I was humbled, but, oh boy, the whole company was so exhausted!

That same year, Vogue and the CFDA nominated you for the prestigious Fashion Fund Award. What was that experience like for you? How did it influence your designs and your business?


It was huge for the business. It was an amazing time in my life to be part of something like that. I wish I was the kind of person who knows how to use a given opportunity and multiply it into millions, but I’m not. I’m not trying to build a huge business…I am more artistic I guess. I prefer to keep my business small and close to my heart so that I want to get up every day and be excited to make something with my hands. I like working in my own way and on my own timeline. With the nature of my design, I’m not meant to have a big business. Or, at least, one that’s just about selling clothes. I can’t be happy seeing my designs lose their quality from cheaper production. So, I’m getting back to doing what I do best, which is making clothes by hand.

You took a break from designing for a few years. What were you doing during that time? Do you feel like the break from the industry altered your approach to design or your views of the industry as a whole?


I got really burned out and needed to clear my head. I knew I didn’t want to keep going the way I was, and I needed to stop in order to see things more clearly. I lived in the Virgin Islands for two years, basically putting a pause on my company in Los Angeles. I was also traveling and spending time with family. During that time, I tried to figure it out how I wanted to approach the business in my own way and not follow others.

You recently moved to New York and are back to designing. What can you tell us about the current collection you’re working on?


I’m going back to my core. I want to do one-of-a-kind pieces. I have incorporated fur into my cashmere designs, which I have not done before. I’m quite satisfied with it.

When you’re not designing, how are you spending your free time?


I started yoga, and I find that it really centers me. I work all the time and I also cook a lot. I also like going to museums and flea markets.

A lot of designers have a sort of clothing uniform. Do you think that you always dress a particular way? What’s your style uniform?


I always get dirty, so I stick with simple pants and a t-shirt.

What is your hair routine?


I wash every other day. I like the natural look.

What do you think is the chicest hairstyle to wear with one of your designs?


I always like women with a natural look. If you have a good haircut, you can be a bit messy with your look. I like hair that falls around the neck at the moment.

Do you have any advice for young designers hoping to break into the industry?


There are so many designers in the industry, yet all the clothes look relatively the same. You need to find you own DNA.
          Bon Duke   
With his boyish good looks, cool crop of hair and signature silver rings, photographer Bon Duke looks as if he belongs in front of the camera as much as he does behind it. Despite his young age, Duke has accrued an impressive body of work: He counts Lindsey Wixon and Coco Rocha as muses and V Magazine, Nylon, 3.1 Phillip Lim and Kanye West as clients. We caught up with Duke and asked him about his latest film collaboration with emerging designer Prabal Gurung, which was created as part of an exclusive project conceived by NOWNESS and the School of Visual Arts. Click on the video above to watch the entire film, and check out his portfolio here.

Your short was part of an exclusive collaboration with the CFDA and School of Visual Arts. What was the selection process like to be a part of this initiative? How were you paired with Prabal Gurung?


The selection process was simple: We were all rotated through the different designers and then each designer was paired with a photographer. Prabal and I connected instantly and knew that we would create an amazing piece together.

How did you come up with the concept for your short film?


We were given a prompt to use an introduction to a movie we liked. I wanted to contrast Prabal's high-end clothing with a movie that was the total opposite. Lords of Dogtown was perfect for this. Creating a female leader that had a pack of skaters following her around really appealed to me…I worked hard to ensure that you knew she was the leader based on her look and attitude.

Why did you decide to name your film “The Erjonas”?


The film is actually named after the model, Erjona Ala.

How would you describe your film and photography aesthetic?


I like to have fun with my films, to create an energy that the viewer can experience. I usually try to create a character that has a confidence and a "cool" feeling to them. My photography, on the other hand, always relates to shape and form. I try to look at the shape of the clothing…I approach it almost like a still life. I also like small imperfections in the photo that I leave to contrast the beauty and flawlessness of the clothes and model.

Your personal style?


White tee, black or blue jeans, leather jacket, and rings. Oh, and Rough Luxury!

Having already collaborated with CFDA winner Prabal Gurung for this short, which designers or artists would you like to work with next?


With respect to designers, I would love to collaborate with Raf Simons or Yohji Yamamoto. In terms of artists, I would love to work with Woodkid. His real name is Yoann Lemoine and he is actually an amazing director. He then jumped into music and adopted the name Woodkid.

What are some of your upcoming projects?


I am shooting a lot of personal video projects that are much more humorous and almost poke fun at the fashion world.

          CFDA 50th Anniversary Runway Retrospective   
Hair by Oribe
June 4, 2012

To celebrate its 50th anniversary, the Council of Fashion Designers of America (CFDA) put on an incredible runway show documenting the past five decades in fashion to kick off its annual awards presentation. Oribe had the honor of creating hair looks to represent each era, and he and his team worked backstage to give each model a distinctive look.

While all the styles were unique to their time period, they had a similar starting point. “We decided to keep the back of the hair the same—tight to the head—while using the section of hair on top to form various shapes and different proportions,” Oribe said. “The looks are extreme, but not campy. They’re all gorgeous and each one has a personality.”



To create the base:
1. Spray Maximista before blow drying hair, then set in large rollers to establish a good base.
2. Clip up the top section of hair.
3. Part the back of the hair in the center.
4. Create two very tight and clean French twists and pin in place, leaving a seam in the middle. Use Imperméable to set. Let the remaining hair from the twists stay loose.



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          Health Highlights: June 30, 2017   
Infant's Infection Spurs Experts to Warn Against Placenta Pills No Emergency Medical Help for 3rd Opioid Overdose: Ohio Councilman FDA to Speed Reviews of Drugs for Rare Diseases
          Health Highlights: June 29, 2017   
FDA to Speed Reviews of Drugs for Rare Diseases
          FDA Allows Marketing Of Test To Aid In The Detection Of Certain Leukemias And Lymphomas    
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          CHF Solutions??? Aquadex Flexflow Aquapheresis System Receives FDA IDE Approval For Clinical Study For Pediatric Use    
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          K2M First-To-Market With 3D-Printed Corpectomy Cage System Following FDA Clearance Of CAPRI Small 3D Static Featuring Lamellar 3D Titanium Technology    
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          FDA, NCI to study cancer proteogenomics together   
The FDA and the National Cancer Institute will collaborate on clinical proteogenomics cancer research, including "statistical -More

          People Are Losing Their Sh*t Over This Picture of IRL Barbie Doll Duckie Thot   

If you take a quick sweep of her Instagram, you'll see that Australian and South Sudanese model Duckie Thot is no stranger to looking pretty much perfect on a daily basis. As an alumna of Australia's Next Top Model (she competed in 2013), Thot knows a thing or two about flashing a killer "smize." But one picture in particular has the internet on its knees, and for good reason. No big deal or anything, but in a picture she posted on Tuesday night, Thot looks exactly like a Barbie doll.

Ducks after dark.

A post shared by Duckie Thot (@duckieofficial) on

Thot looks so Barbie-esque; she better get at least a walk-on role in the upcoming Life Size 2 (although with those looks, she could star in the damn thing). Just about everyone on Instagram agreed, with one user commenting, "Real life Barbie." One added, "I showed this picture to my baby girl & she wanted that doll." Another proclaimed, "MY LIFE HAS BEEN OFFICIALLY SLAYED," and I agree.

But the best response to the frenzy was Thot's own.

While it's so heartening to see a mega-talented model like Thot be appreciated for her work, unfortunately that hasn't always been the case. Last year, fellow model Winnie Harlow made an offensive comment about Thot's natural hair, which she later rescinded via an Instagram apology. Thot clapped back, writing, "It's not fun being bullied for something you can't control and to have a top model woman of colour who I thought encouraged acceptance and self love call me out for rocking my natural hair."

Despite this feud, Thot keeps slaying like the beautiful Barbie she is.

that sundress tho...

A post shared by Duckie Thot (@duckieofficial) on

Hands on 🤘🏿

A post shared by Duckie Thot (@duckieofficial) on



          Comment on Rescue Dog Journal: Pet Therapy Dog Graduate by JamesPix   
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          EFDA Dental Assistant - Barnes Dental - Portland, OR   
We are looking for an EFDA dental assistant to join our team. We are a patient driven practice that enjoys working together and having fun. Job Type: Full
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          Sintesi della Guida FDA sulle interazioni Farmaci-Alimenti   

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          alikhan4312 posted a blog post   
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          ေျမြေပြးႏွင့္ ေျမြေဟာက္အဆိပ္ႏွစ္မ်ိဳးလံုးကို ေျဖေပးႏိုင္သည့္ အဆိပ္ေျဖေဆးထုတ္လုပ္ထားၿပီး ေဆးဝါးမွတ္ပံုတင္လိုင္စင္ရရွိပါက ေစ်းကြက္တြင္း ျဖန္႔ျဖဴးသြားမည္   
ေျမြေပြးနဲ႔ ေျမြေဟာက္ အဆိပ္ႏွစ္မ်ိဳးလံုးကို ေျဖေပးႏိုင္တဲ့ အဆိပ္ေျဖေဆးထုတ္လုပ္ထားၿပီး ေစ်းကြက္တြင္း ျဖန္႔ျဖဴးႏိုင္ဖို႔ FDA မွေဆးဝါးမွတ္ပံုတင္လိုင္စင္ ေလွ်ာက္ထားဆဲျဖစ္ၿပီး ရရွိပါကေစ်းကြက္တြင္း ျဖန္႔ျဖဴးသြားမွာျဖစ္တယ္လို႔ သိရပါတယ္။
          ရန္ကုန္ၿမိဳ႕ု ဘုရင့္ေနာင္ေစ်းအတြင္းရွိ အစားအစာမ်ားတြင္ ခြင့္မျပဳဆိုးေဆးမ်ား၊ တားျမစ္ဓါတုပစၥည္းမ်ား ပါဝင္ျခင္းရွိမရွိကို FDA ကဦးေဆာင္ၿပီး ေရွာင္တခင္စစ္ေဆး   
ျမန္မာႏုိုင္ငံ အစားအေသာက္နဲ႔ ေဆးဝါးကြပ္ကဲေရးဦးစီးဌာန FDA ကဦးေဆာင္ၿပီး အစားအစာေတြမွာ ခြင့္မျပဳဆိုးေဆးေတြ၊ တားျမစ္ဓါတုပစၥည္းမ်ား ပါဝင္ျခင္းရွိမရွိကို ဇူလိုင္လ ၁ ရက္ေန႔မွာ ရန္ကုန္ၿမိဳ႕ ဘုရင့္ေနာင္ေစ်းအတြင္း ေရွာင္တခင္ကြင္းဆင္း စစ္ေဆးျခင္းျပဳလုပ္ခဲ့တယ္လို႔ သိရပါတယ္။
          ဇူလိုင္လ ၂ ရက္ေန႔ နံနက္ပိုင္း သတင္းအစီအစဥ္   
■ တိုင္းေဒသႀကီးႏွင့္ ျပည္နယ္မ်ားတြင္ စက္မႈဇုန္အသစ္မ်ား တည္ေထာင္ရန္ MIC စီစဥ္ေန ■ ပုဂံေရွးေဟာင္းယဥ္ေက်းမႈေဒသ၏ ေန၀င္ေနထြက္ခ်ိန္ကုိ ၾကည့္ရႈႏုိင္ရန္ ကန္သုံးကန္ကုိ ကန္ေဘာင္ျမွင့္ တည္ေဆာက္ေန ■ ရန္ကုန္ၿမိဳ႕ ဘုရင့္ေနာင္ေစ်းအတြင္းရွိ အစားအစာမ်ားတြင္ ခြင့္မျပဳဆိုးေဆးမ်ား၊ တားျမစ္ဓါတုပစၥည္းမ်ား ပါဝင္ျခင္းရွိမရွိကို FDA ကဦးေဆာင္ၿပီး ေရွာင္တခင္စစ္ေဆး ■ ေျမြေပြးႏွင့္ ေျမြေဟာက္ အဆိပ္ႏွစ္မ်ိဳးလံုးကို ေျဖေပးႏိုင္သည့္ အဆိပ္ေျဖေဆး ထုတ္လုပ္ထားၿပီး ေဆးဝါးမွတ္ပံုတင္လိုင္စင္ရရွိပါက ေစ်းကြက္တြင္း ျဖန္႔ျဖဴးသြားမည္ ■ ထိုင္၀မ္ကို အေမရိကန္က ေဒၚလာ ၁.၄၂ ဘီလီယံဖိုး လက္နက္ေရာင္းခ်မည့္ အစီအစဥ္အား တရုတ္ကန္႔ကြက္ ■ ၿဗိတိန္ႏွင့္ ျပင္သစ္ႏိုင္ငံၾကား ပင္လယ္ေရျပင္တြင္ ဆီသယ္သေဘၤာတစ္စီးႏွင့္ ကုန္တင္သေဘၤာတစ္စီးတိုက္မိ ■ ေျမာက္ကုိရီးယားႏုိင္ငံသားမ်ားကုိ အလုပ္လုပ္ခြင့္ပါမစ္ ထုတ္ေပးမႈ ရပ္ဆုိင္းထားသည္ဆုိသည္မွာ မွန္ကန္မႈမရိွေၾကာင္း […]
          Business Game Changers Radio with Sarah Westall: The Miracle of Adult Human Stem Cells - Is the FDA Blocking Safe and Effective Treatments for Suffering Americans?   
EpisodeThe FDA has been scrutinized for blocking promising treatments and research for many chronic diseases and conditions. It has also been accused of being significantly behind the rest of the developed world at allowing new treatments into the U.S. market. On the other hand, they claim that their work is to protect the American people and any delays are to protect people. But who to believe? The truth is more complicated then it appears and an easy answer does not exist. The FDA does keep bad ...
          Простые советы по инвестированию в отрасль фармацевтики и медицинских устройств   

Отрасль фармацевтики и медицинских устройств, возможно, является одной из (если не самых) трудных отраслей для понимания и инвестирования. Проведение клинических испытаний, соблюдение процессов одобрения FDA, увеличение бюджетов исследований, отзывы, переполненные рынки, доступ к лекарствам и устройствам после одобрения — это некоторые из ежедневных препятствий, которые фармацевтические и медицинские компании должны преодолевать, в не зависимости от того, большие они или маленькие.

Чтобы проиллюстрировать, насколько фатальным может быть один день в мире фармацевтических препаратов, посмотрим на Opthotech (OPHT). Opthotech объявила результаты двух клинических испытаний 3 фазы, во время которой исследовали, принесет ли сочетание анти-PDGF-терапии FVista® с анти-VEGF-терапией Lucentis® против только терапии Lucentis®, пользу пациентам, страдающим от влажной формы возрастной макулярной дегенерации.

Не было найдено никаких улучшений, и акции OPHT упали с $38 за акцию в пятницу 9 декабря 2016 года до примерно $5 за акцию в понедельник, 12 декабря. Вскоре после этого неудачного исследования OPHT была вынуждена сократить около 80% своего персонала и в настоящее время торгуется около $2,90 за акцию.

Подобная история приходит на ум, когда компания Eli Lilly (LLY) сообщила, что ее потенциальное лекарство Solanezumab не смогло продемонстрировать значительную пользу пациентам с диагнозом болезнь Альцгеймера. Это нанесло серьезный удар не только по пациентам, но и научному сообществу и самой Eli Lilly, акции которой упали с $76 за акцию 22 ноября и до $68 за акцию 23 ноября. Потребовался еще один месяц, чтобы Eli Lilly смогла оправиться от этого удара, и в настоящее время компания торгуется на уровне $84 за акцию.

Вот несколько советов, которые могут быть полезными для новичков.

№ 1 — Убедитесь, что регулярно смотрите в «Календарь FDA».

Отзыв, завершающее ответное письмо (CRL) и внезапное окончание клинических испытаний — события, непредвиденные по своей природе. Однако у одобрений FDA есть приблизительные даты. Biopharm Catalyst и Valinv — это отличные ресурсы, на которых можно узнать, какие препараты должны быть одобрены или отклонены FDA и когда. Также важно понимать, что такие проблемы, как CRL, не означают, что препарат отклонен, но заявка на одобрение препарата не может двигаться вперед для принятия решения из-за любой проблемы, такой как производство. Знание того, когда лекарства должны быть одобрены, имеет решающее значение для сроков. Например, компания Adamis (ADMP) недавно получила одобрение на продажу предварительно заполненных шприцев с адреналином. Сам по себе адреналин не защищен никаким патентом, и разработка таких шприцев считается дженериком. После утверждения 14 июня акции ADMP выросли примерно на 53%, а приблизительная дата этого утверждения была заявлена онлайн до того, как FDA вынесла свое решение.

№ 2 — Просто потому, что фармацевтическая компания имеет типичные «признаки покупки» как у других компаний, это не означает покупку.

Например, компания Gilead (GILD) получила известность за преобразование того, как мы лечим СПИД/ВИЧ, и успешно продала эффективное лечение гепатита С. Gilead также была прибыльной с 2003 года, имеет текущий коэффициент P/E менее 8, EPS примерно 9,4, значительные денежные средства.

Процент акций, проданных в короткую, в настоящее время составляет 0,83%, и все же для Gilead все было довольно плохо, несмотря на быстро развивающийся рынок. В январе 2016 года акции Gilead упали с примерно $119 за акцию, до нынешней цены в $70.

Другими словами, Gilead сокращается как компания и будет продолжать делать это, если только она не сделает еще одно значительное приобретение, как Triangle Pharmaceuticals и Pharmasset для продажи своих препаратов против ВИЧ и гепатита С. Но даже после того, как будет осуществлено значительное приобретение, лучше оставаться осторожным и определить, может ли это приобретение принести выручку.

№ 3 — Редкая и неприбыльная компания не означает, что ее нужно избегать.

Это, по общему признанию, нелогично, особенно в мире вэлью инвестирования и нахождения компаний с долгосрочным ростом. Например, у BioMarin (BMRN) есть солидный портфель лекарственных средств в разработке, шесть продаваемых препаратов и исключительную направленность на лечение редких заболеваний.Хотя для фармацевтической компании может показаться невозможным добиться успеха, если производить лекарства для лечения ограниченного числа пациентов, BioMarin все делает замечательно, и в ближайшие годы может стать прибыльной.В дополнение к увеличению выручки с 2003 года (с $12 млн до $1,1 млрд), а соотношение долга и собственного капитала, по существу, стабильное с 2010 года (от 0,25 до 0,45), BioMarin позиционируется лучше, чем многие полагали бы для долгосрочного роста.

Наконец, BioMarin также может воспользоваться Законом об орфанных лекарственных препаратах 1983 года. Этот акт поощряет фармацевтические компании разрабатывать лекарства и методы лечения заболеваний, которые в противном случае не привлекли бы внимания из-за их редкости. Одно из наиболее интересных и потенциально выгодных преимуществ получения одобрения препарата, который лечит редкую болезнь (и имеет педиатрическую маркировку), это получить ваучер от FDA, который «быстро отслеживает» рассмотрение любого выбранного препарата примерно в течение 10-6 месяцев. Эти три-четыре месяца невероятно ценны, потому что все фармацевтические компании участвуют в гонках патентов, чтобы увеличить выручку до того, как их препарат станет кандидатом на дженерик. Эти ваучеры также можно продать другим компаниям за любую цену, а краткое описание таких продаж приведено ниже.


Таким образом, продвижение по отрасли фармацевтики и медицинского оборудования сложно, а иметь достаточно знаний и уверенности в себе, чтобы инвестировать в эту отрасль, еще сложнее.


          FDA Allows Two New Cigarettes to Hit Market   
Title: FDA Allows Two New Cigarettes to Hit Market
Category: Health News
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          Few Patients Should Get Metal-on-Metal Hip Implants, FDA Panel Says   
Title: Few Patients Should Get Metal-on-Metal Hip Implants, FDA Panel Says
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          FDA Approves New Overactive Bladder Drug   
Title: FDA Approves New Overactive Bladder Drug
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Title: FDA Approves Diet Pill Belviq
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          FDA Probing Safety of Metal-on-Metal Hip Implants   
Title: FDA Probing Safety of Metal-on-Metal Hip Implants
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Title: FDA Delays Decision on Blood Thinner Eliquis
Category: Health News
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Title: FDA Rejects New Use for Blood Thinner Xarelto
Category: Health News
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Last Editorial Review: 6/25/2012 12:00:00 AM
          FDA Unveils Graphic Images for Cigarette Packs   
Title: FDA Unveils Graphic Images for Cigarette Packs
Category: Health News
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Title: FDA Panel Rejects Gout Drug on Safety Concerns
Category: Health News
Created: 6/22/2011 11:01:00 AM
Last Editorial Review: 6/22/2011 12:00:00 AM
          FDA Prepares for Nanomedicine Revolution   
Title: FDA Prepares for Nanomedicine Revolution
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Created: 6/22/2011 11:01:00 AM
Last Editorial Review: 6/22/2011 12:00:00 AM
          'Female Viagra' Is Rejected by FDA Panel   
Title: 'Female Viagra' Is Rejected by FDA Panel
Category: Health News
Created: 6/21/2010 10:59:00 AM
Last Editorial Review: 6/21/2010 10:59:18 AM
          FDA Blocks Some Fish From China   
Title: FDA Blocks Some Fish From China
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Last Editorial Review: 6/29/2007 12:00:00 AM
          FDA OKs Drug for Parkinson's Dementia   
Title: FDA OKs Drug for Parkinson's Dementia
Category: Health News
Created: 6/29/2006 12:00:00 AM
Last Editorial Review: 6/29/2006 12:00:00 AM
          FDA OKs 1st Generic Version of Zocor   
Title: FDA OKs 1st Generic Version of Zocor
Category: Health News
Created: 6/26/2006 12:00:00 AM
Last Editorial Review: 6/26/2006 12:00:00 AM
          What are the requirements for CERs in CFDA medical device registration?   

Grace fu Palma, founder and CEO, China Med Device China introduced new requirements for clinical evaluation reports in 2015. Understanding the China Food and Drug Administration’s new CER requirements can help companies to be better prepared in their CFDA submissions. The CER must summarize the data from the clinical literature, clinical experience, and clinical trials,

The post What are the requirements for CERs in CFDA medical device registration? appeared first on Medical Design and Outsourcing.


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          FDA OKs new drug for advanced prostate cancer   
The Food and Drug Administration said Friday it approved the pill Xtandi for men with advanced prostate cancer that has returned or spread despite major medical intervention.
          Novartis: Starke Zahlen?   
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          BioMarin Submits Pegvaliase Biologics License Application (BLA) to the U.S. FDA for Treatment of Phenylketonuria (PKU)   

SAN RAFAEL, Calif., June 30, 2017 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced that the company submitted a Biologics License Application (BLA) on Friday, June 30, 2017 to the U.S. Food and Drug Administration (FDA) for pegvaliase, a PEGylated recombinant phenylala...



          Regulatory Affairs Associate III, Pre Approval - Teva Pharmaceuticals - Parsippany, NJ   
Interacts with FDA and all Teva sites via written and phone communications. Interpersonal Demonstrates ability to establish sound professional relationships...
From Teva Pharmaceuticals - Fri, 31 Mar 2017 16:03:18 GMT - View all Parsippany, NJ jobs
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          Comment on Top 15 Contaminated Fish You Shouldn’t be Eating by Excelsior   
The FDA doesn't tell you what's safe. They tell you what the safe levels are to consume. They give you the numbers and you can do with them whatever the hell you want. You can eat Atlantic fish, Pacific fish, or fish pulled out of a storm drain. Or you can eat tofu your entire life. Who cares?
          System F-5FDA (Scalding Pass) held by The Bastard Cartel has been upgraded (0 -> 1)   
System F-5FDA (Scalding Pass) held by The Bastard Cartel has been upgraded (0 -> 1)
          FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas   
The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN).
          FDA unveils plan to eliminate orphan designation backlog   
Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to all new requests for designation within 90 days of receipt during his testimony before a Senate subcommittee.
          FDA 授予强生利伐沙班补充新药申请优先审查   
美国医药巨头强生(JNJ)旗下杨森研发部门近日宣布,美国食品和药物管理局(FDA)已受理抗凝血剂 Xarelto(中文品牌名:拜瑞妥,通用名:rivaroxaban,利伐沙班)的一份补充新药申请(sNDA)并授予了优先审查资格。该 sNDA 纳入了每日 10mg 剂量 Xarelto 用于已接受至少 阅读全文
          PERKEMBANGAN MASA DEWASA AWAL   

A. Perkembangan Fisik

1. Transmisi dari Masa Remaja Menuju Masa Dewasa

Transmisi anak dari masa remaja menuju masa dewasa di awali dengan masa muda dan criteria untuk menjadi dewasa. Masa muda (youth) adalah istilah ahli sosiologi Kenneth Kenniston untuk periode transisi antara masa remaja dan masa dewasa yang merupakan masa perpanjangan kondisi ekonomi dan pribadi yang sementara.

Dua criteria yang diajukan untuk menunjukkan akhir masa muda dan permulaan dari masa dewasa awal adalah kemandirian ekonomi dan kemandirian dalam membuat keputusan. Mungkin yang paling luas diakui sebagai tanda memasuki masa dewasa-adalah ketika seseorang mendapatkan pekerjaan penuh waktu yang kurang lebih tetap. Factor pendidikan juga mempengaruhi hasil kerja seseorang dan pekerjaan yang didapatnya. Mendapatkan kemandirian ekonomi terlepas dari orang tua berlangsung secara bertahap, dan bukan proses yang tiba-tiba. Tidak aneh menemukan lulusan universitas yang memperoleh pekerjaan dan tetap tinggal atau kembali tinggal serumah dengan orangtuanya, terutama dalam iklim ekonomi dewasa ini.

Kemampuan untuk membuat keputusan adalah cirri lain yang tidak sepenuhnya terbangun pada kaum muda. Yang dimaksud disini adalah pembuat keputusan secara luas tentang karir, nilai-nilai, keluarga dan hubungan, serta tentang gaya hidup. Pada waktu muda, seseorang mungkin mencoba banyak peran yang berbeda, mencari karir alternative, berpikir tentang gaya hidupdan mempertimbangkan berbagai hubungan yang ada. Individu yang beranjak dewasa biasanya membuat keputusan tentang hal-hal ini, terutama dalam bidang gaya hidup dan karir.

2. Perkembangan Fisik

a. Puncak dan penurunan kemampuan fisik

Tercapainya kekuatan dan kecepatan puncak terjadi relative lebih awal, dibandingkan dengan tercapainya keterampilan motorik dan kognitif yang beragam. Meskipun demikian, dalam beberapa tahun ini sudut pandang biologis terhadap kemampuan puncak telah diperluas untuk beberapa kasus individual.

Kita tidak hanya mencapai puncak kemampuan fisik kita pada awal masa dewasa, dalam masa ini kita juga dalam kondisi yang paling sehat. Hanya sedikit orang dewasa muda yang memiliki masalah kesehatan kronis, dan mereka mengalami flu dan masalah pernapasan yang lebih sedikit dibandingkan pada saat mereka anak-anak.

Ketika seorang individu berpindah dari masa remaja menuju masa dewasa awal, mereka seringkali meningkatkan penggunaan obat-obatan. Pada masa dewasa awal, beberapa individu berhenti berpikir tentang bagaimana gaya hidup pribadi akan mempengaruhi kesehatan mereka selanjutnya pada kehidupan dewasa. Sebagai seorang dewasa yang masih muda, banyak dari kita membangun sebuah pola seperti tidak sarapan, tidak makan makanan secara teratur, dan menggantungkan diri pada makanan kecil sebagai sumber makanan utama dalam sehari, makan secara berlebihan sampai kita melampaui berat normal untuk umur kita, merokok dalam taraf sedang atau berlebih, minum minuman keras dalam taraf sedang aau berlebih, tidak berolahraga, dan tidur dengan waktu yang sedikit tiap malam. Gaya hidup pribadi yang buruk ini berhubungan dengan kondisi kesehatan yang buruk.

Terdapat beberap bahaya yang tersembunyi dalam masa puncak kemampuan dan kesehatan pada masa awal dewasa. Pada saat kaum dewasa awal dapat menggunakan sumber daya fisik untuk banyak kesenangan, ditambah kenyataan bahwa seringkali mereka pulih dengan mudah dari stress fisik dan cidera, menjadikan mereka memaksa tubuh terlalu jauh. Akibat negative dari penyalahgunaan tubuh seseorang mungkin tidak terlihat pada permulaan masa dewasa awal, tetapi nantinya mungkin muncul pada masa dewasa awal lebih lanjut atau pada pertengahan masa dewasa.

Kondisi kesehatan kaum muda dapat ditingkatkan dengan mengurangi gaya hidup yang merusak kesehatan, seperti makan terlalu banyak, dan engan menerapkan gaya hidup yang meningkatkan kesehatan yang mencakup nutrisi yang baik dan olah raga.

b. Nutrisi dan perilaku makan

Yang pertama akan kita bahas adalah tentang kelebihan berat badan. Memahami masalah berat badan adalah rumit, karena berat badan melibatkan warisan genetic, mekanisme fisiologis, factor kognitif dan pengaruh lingkungan (Brownell,1991), dahulu, komponen genetic dianggap tidak berpengaruh oleh para ilmuan; temuan penelitian baru-baru ini menunjukkan bahwa beberapa individu mewarisi kecenderungan kelebihan berat badan.

Jumlah lemak yang tersimpan dalam tubuh adalah factor penting yang merupakan titik acuan, yaitu berat badan tetap pada waktu tidak ada upaya untuk menambah atau mengurangi berat. Ahli kesehatan juga menyimpulkan bahwa tingkat metabolism penting untuk diperhitungkan dalam usaha memahami masalah berat badan. Basal metabolism rate (BMR) adalah jumlah energy minimum yang digunakan seorang individu pada saat istirahat.

Amphetamin banyak digunakan oleh pelaku diet karena menghilangkan nafsu makan. Pengurangan berat badan dengan amphetamine biasanya berlangsung dalam waktu singkat, dan seringkali memiliki efek samping yang merugikan, seperti meningkatkan tekanan darah dan kemungkinan kecanduan.

Olahraga adalah alternative yang lebih menarik daripada obat penurun badan seperti amphetamine. Olahraga tidak hanya membakar kalori tetapi juga meninkatkan metabolism. Oleh karena itu, yng penting untuk diingat, agar berhasil mengontrol berat badan adalah: (1) jangan melakukan diet, tetapi ubahlah kebiasaan agar berat turun perlahan dan stabil kurang dari sat upon seminggu;(2) makan lebih sedikit kalori dan terutama lebih sedikit lemaknya;(3) menambah olahraga secara teratur.

c. Olah raga

Aerobic adalah olah raga yang mempertahankan gerakan berulang-ulang, berenang, atau berspeda, sebagai contoh-yang menstimulasi aktivitas jantung dan paru-paru (Cooper,1970). Penelitian tentang akibat olah raga pada kesehatan telah difokuskan terutama pada pencegahan penyakit jantung. Risiko serangan jantung juga dapat dikurangi sebanyak kurang lebih sepertiga dalam periode 7 tahun dengan olah raga tingkat sedang seperti jalan cepat dan berkebun.

Penelitian tentang manfaat olah raga menunjukkan baik kegiatan yang intensif maupun yang sedang menghasilkan keuntungan fisik dan psikologis (Brown,1991;Plante & Rodin,1990).

d. Ketergantungan dan pemulihan

Semua orang dapat membentuk ketergantungan pada banyak hal, tetapi ketergantungan pada obat-obatan terlarang adalah ketergantungan yang paling menonjol dan menyimpang. Dalam hal ini, ketergantungan adalah ketergantungan fisik pada suatu obat. Penarikan diri adalah rasa sakit yang tidak diinginkan dan ketagihan yang dialami oleh penderita ketergantungan pada saat obat-obatan yang dibutuhkan tidak ada. Ketergantungan psikologis adalah kebutuhan untuk menggunakan obat-obatan untuk mengatasi masalah dan stress. Baik dalam ketergantungan fisik dan psikologis, obat-obatan psikoaktif(semua obat yang mempengaruhi system syaraf untuk mengubah kondisi kesadaran, mengubah persepsi, dan mengubah suasana hati)berperan secara kuat, biasanya merusak hidup si pengguna.

Alcohol adalah obat psikoaktif yang paling luas digunakan, meskipun perhatian terhadap penyalahgunaan kokain meningkat pada tahun-tahun belakangan. Pengaruh alcohol terhadap tubuh terutama sebagai suatu depresan dan memperlambat kegiatan otak. Ketika orang meminum alcohol berlebih, rasa malu menjadi berkurang lebih banyak dan keputusan mereka semakin tidak sempurna. Alkoholisme cenderung meurun dalam keluarga. Kenyataan ini mendorong pra peneliti mempelajari pengaruh penting factor keturunan dalam alkohoisme (Prescott dkk.,1994;Schuckit,1994).

3. Seksualitas dan AIDS

v Sikap dan perilaku seksualitas

a. Sikap dan perilaku heteroseksual

Dua aspek dari sikap dan perilaku heteroseksual yang penting untuk dipertimbangkan adalah standar ganda dan hakekat seks di luar nikah. Manifestasi dari standar ganda adalah kepercayaan yang salah yang menyatakan bahwa adalah salah bagi perempuan untuk merencanakan hubungan seksual (dengan menggunakan alat kontrasepsi) tetapi diperbolehkan bagi mereka untuk terhanyut oleh gairah sesaat.

Standar ganda juga terjadi dalam hubungn di luar nikah, meskipun tidak seluas dalam tahun-taun sebelumnya.

b. Sikap dan perilaku homoseksual

Orientasi seksual individu-heteroseksual maupun homoseksual tampaknya lebih banyak ditentukan oleh kombinasi antara factor genetic, hormonal, kognitif, dan lingkungan (McWhirter, Reinisch & Sanders, 1989; Money, 1987; Savin-Williams &Rodriguez, 1993; Whitman, Diamond & Martin,1993). Sebagian besar ahli dalam hal homoseksualitas percaya bahwa tidak ada factor tunggal yang menyebabkan homoseksualitas dan bobot relative masing-masing factor berbeda-beda dari satu individu ke individu yang lain. Satu dari factor biologis yang dipercaya berpengaruh dalam homoseksualitas adalah keadaan hormone prenatal (Ellis & Ames,1987).

Bagi perempuan lesbian atau laki-laki gay, membangun identitas bicultural menciptakan jalan baru untuk mendefinisikan diri mereka. Perhatian khusus pada kehidupan gay dan lesbian adalah bias dan diskriminasi yang mereka hadapi.

v AIDS

AIDS adalah suatu penakit menular seksual yang disebabkan oleh virus, human immunodeficiency virus (HIV), yang menghancurkan system ketahanan tubuh. Setelah terjangkit HIV, individu akan menjadi rentan terhadap kuman yang biasanya dapat dihancurkan oleh system kekebalan tubuh yang normal. HIV pertama kali dikenal di Amerika Serikat pada tahun 1981.

Para ahli menyatakan bahwa AIDS hanya dapat ditularkan melalui hubungan seksual, penggunaan jarum suntik bersama, atau transfuse darah. Meskipun 90 % dari semua kasus AIDS terjadi diantara laki-laki homoseksual dan penggunaan obat-obatan terlarang yang menyuntikkannya dalam pembuluh darah, baru-baru ini tercatatadanya peninkatan yang tidak proporsional diantara para perempuan yang memiliki pasangan heteroseksual laki-laki biseksual dan penggunaan obat-obatan terlarang yang menyuntikkannya kedalam pembuluh darah. Peningkatan ini menunjukkan bahwa risiko tertular AIDS mungkin meningkat diantara individu heteroseksual yang memiliki banyak pasangan seks (Boyer & Hein,1991; Krijnen, van den hoek & Coutinho,1994).

Siapapun yang aktif secara seksual atau yang menyuntikkan obat-obatan kedala pembuluh darah berisiko terinfeksi. Tidak seorangpun kebal. Sekali seseorang terinfeksi, prognosisnya adalah terserang dan meninggal. Satu-satunya perilaku yang aman adalah tidak melakukan hubungan seks, namun hal ini tidak dipandang sebagai pilihan bagi sebagian besar individu. Selain tidak melakukan hubungan seksual, cara lain yang lebih aman adalah melakukan hubungan seksual dengan menggunakan kondom (Cox,1994).

Pada fase pertama dari penyakit tersebut-HIV+ dan asimptotamik- individu tidak menunjukkan tanda-tanda terserang penyakit AIDS tetapi dapat menularkan penyakit tersebut. Pada fase 2-HIV+ simptomatik- jumlah yang tidak diketahui yang terkena penularan diam-diam menunjukkan gejala-gejala penyakit, diantaranya membengkaknya kelenjar getah bening, kelelahan, hilangnya berat tubuh, diare, demam, dan berkeringat. Banyak yang menderita HIV+ dan simptomatik berlanjut ke fase terakhir-AIDS. Seseorang dengan AIDS memiliki gejala AIDS ditambah satu atau dua gejala penyakit, seperti pneumonia, yang akan sangat fatal bagi pasien AIDS karena kerentanan system kekebalan tubuh mereka. Meskipun tidak ada pengobatan yang diketahuiuntuk AIDS, beberapa obat telah di uji coba, termasuk AZT, atau zidovudine, disetujui oleh FDA untuk mengobati symptom AIDS di tahun 1987.

B. Perkembangan Kognitif

1. Fase-fase kognitif

Di dalam perkembangan kognitif, ada beberapa macam fase menurut Schaie, yaitu:

a Fase mencapai prestasi (achieving stage) adalah fase dimasa dewasa awal yang menurut Schaie (1977), melibatkan penerapan intelektualitas pada situasi yang memiliki konsekuensi besar dalam mencapai tujuan jangka panjang, seperti pencapaian karir dan pengetahuan.

b Fase tanggung jawab (the responsibility stage) adalah fase yang terjadi ketika keluarga terbentuk dan perhatian diberikan pada keperluan-keperluan pasangan dan keturunan.

c Fase eksekutif (the executive stage)adalah fase yang dinyatakan oleh Schaie terjadi di masa dewasa tengah, dimana seseorang bertanggung jawab kepada system kemasyarakatan dan organisasi sosial (pemerintah atau perusahaan, misalnya). Dalam fase eksekutif individu membangun pemahaman tentang bagaimana organisasi sosial bekerja dan berbagai hubungan kompleks yang timbul didalamnya.

d Fase reintegratif (the reintegrative stage), yang terjadi pada bagian akhir masa dewasa, adalah fase terakhir yang disebutkan oleh Schaie, dimana orang dewasa yang lebih tua memilih untuk memfokuskan tenaga mereka pada tugas dan kegiatan yang bermakna bagi mereka.

2. Kreatifitas

Beberapa tokoh yang mempunyai daya kreatifitas yang tinggi, diantaranya adalah:

a Thomas Alfa Edison menemukan fonograf pada usia 30-an tahun;

b Hans Christian Andersen menulis kumpulan cerita dongeng pertamanya;

c Mozart menciptakan komposisi the marriage of Figaro.

Dalam beberapa penelitian, kualitas produktifitas orang dewasa yang terkenal mencapai puncak tertinggi pada usia 30 tahun; hampir 80% sumbangan kreatif terpenting diselesaikan pada usia 50 tahun (Dennis,1966; ehman,1960). Titik pada perkembangan orang dewasa dimana kreativitas memuncak berbeda dari disiplin yang satu ke disiplin yang lain. Dalam humaniora, pada usia tujuh puluhan kreativitas sama dengan pada usia empat puluhan. Namun, ilmuan dan seniman mulai menunjukkan penurunan kreativitas pada usia lima puluhan. Pada semua contoh, usia dua puluhan adalah decade dengan produktivitas terendah dalam masalah kreativitas. Ada beberapa perkecualian, tentu saja. Dalam sains,Bejamin Duggar menemukan antibiotic auremycin ketika dia berusia 72 tahun. Makalah utama pertama dari pemenang nobel dipublikasikan rata-rata pada usia 25 tahun. Namun semua penerima nobel yang melewati usia 70 tahun, terus-menerus mempub

          Regulatory Affairs Associate III, Pre Approval - Teva Pharmaceuticals - Parsippany, NJ   
Interacts with FDA and all Teva sites via written and phone communications. Interpersonal Demonstrates ability to establish sound professional relationships...
From Teva Pharmaceuticals - Fri, 31 Mar 2017 16:03:18 GMT - View all Parsippany, NJ jobs
          Sales Executive   
VIC-Richmond, Due to recent expansion, a Account Executive is needed to manage food service key accounts. Reporting to the National Sales & Marketing manager, you will be calling on leading Foodservice distributors including PFD & Bidvest, independent distributors, Countrywide & NAFDA members and key end users within Victorian metro/rural areas. Some overnight interstate travel as required. You will be managing
          Deadly Bacteria Lands Cheese Manufacturer with FDA Lawsuit   

After repeated warnings, the Food and Drug Administration has filed a suit in Federal District Court in Brooklyn in an attempt to shut down a Queens, NY cheese manufacturer for health violations involving the presence of deadly bacteria. Mexicali Cheese Corporation located in Woodhaven—a neighborhood in Queens—has a history of health violations that include findings […]

The post Deadly Bacteria Lands Cheese Manufacturer with FDA Lawsuit appeared first on Organic Authority.


          Hepatitis C is a pediatric disease now   
Commentary
Hepatitis C is a pediatric disease now
Publish date: June 27, 2017
By: Kristina K. Bryant, MD
It is estimated that there are 23,000 to 46,000 U.S. children living with HCV. The wait for pediatricians is over. HCV is a pediatric disease now, and we need to educate ourselves about diagnosis and management. A first step might be to begin asking expectant mothers and the mothers of newborns if they know their HCV status.
Continue reading....
Follow @IDPractitioner  

Recommended Reading
Hepatitis C increasing among pregnant women
Published:



FDA approves two hepatitis C drugs for pediatric patients
Published: April 7, 2017
The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults.
Read the announcement @ FDA Newsroom

FDA Approval Of Hepatitis C Drugs For Kids Is Likely To Speed Treatment






I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading full text articles about the treatment and management of hepatitis C. 


          Edible Mini Butterflies - Rainbow Polka Dots 2 dozen - Cake & Cupcake toppers - Food Decorations by SugarRobot   

3.98 USD

Super cute mini rainbow polka dot butterflies

-*Please read shipping & policies info before you place your order for estimated shipping and delivery times

-You will receive 24 of these beauties. Wing span is approx. 7/8 of an inch

-Precut and ready to use

-Made of wafer paper (potato starch, vegetable oil, water) and food color. FDA approve print
Each butterfly has been brushed with a coat of organic vanilla flavoring. The coat provides stability and a light shine.

-Gorgeous on cupcakes or to use as accents on larger cakes. Use a dab of regular frosting to adhere to most food items and wine glasses/ serving dishes.

-Use within 4 months of receiving them. Store in the packaging they arrive in. Each item is sealed for optimum freshness. Do not refrigerate.

★★★★ All Items are Gluten Free and 100% Vegan ★★★★
Although there are no nuts in the ingredients - Sugar Robot's production facilities are NOT a tree nut free environment.


          Wedding Cake Topper Edible Dragonflies - Assorted Purple- Cake and Cupcake toppers - set of 30 precut by SugarRobot   

21.95 USD

These lifelike Dragonflies are completely edible!

Sugar Robot is the ORIGINAL source for Edible Dragonflies- our high quality items are pre-cut, vacuum sealed, and ready to use.

-*Please read shipping & policies info before you place your order for estimated shipping and delivery times

-You will receive 30 of these beauties.

-Wing spans vary from 3.5 inches to 1.5 inches

-Precut and ready to use

-Made of wafer paper (potato starch, vegetable oil, water) and food color. FDA approved print.
Each dragonfly has been brushed with a coat of vanilla.

-Gorgeous on cupcakes or to use as accents on larger cakes. The cake used in the item photos is a 3 tier wedding cake with a 14 inch base.


..ƸӜƷ.. We have this set available in a variety of colors. Check them out in our 'Dragonflies' section.

http://www.etsy.com/shop/SugarRobot?section_id=7402927


Use within 4 months of receiving them. Store in the packaging they arrive in. Each item is sealed for optimum freshness. Do not refrigerate.

★★★★ All Items are Gluten Free and 100% Vegan ★★★★
Although there are no nuts in the ingredients - Sugar Robot's production facilities are NOT a tree nut free environment


          Logistics Coordinator   
• Report to the Logistics Manager • A Logistics Coordinator must be able to communicate effectively since the job primarily involves liaising with clients, couriers and other operational departments such as finance, after sales service and sales teams; etc. • Support Sales Teams with freight solutions, estimates and budgets involved in Myanmar • Responsible for maintaining a record of all logistics expenses such as freight, customs duty, tax and customs broker fees and transportation, etc., • Provide shipment information to customers • Supervise on cargo loading & unloading operations • Obtaining MIC permits, Import License and FDA certificates from Government Department • Working closely with oversea supplier and local logistics suppliers: freight forwarders, trucking companies, carriers, shipping lines, customs brokers and customers to improve operations and reduce cost and achieving maximum efficiency by making cost comparisons • Monitoring deliveries, ensuring customer satisfaction and maintaining accurate logistics cost of all transportation and goods • Survey the final place of delivery as and when required • Liaises with government authorities as and when required • Communication with clients, efficiency and the resolution of the issues • Develop and maintain consistent processes for inbound/outbound logistics operations ‘in country’ for all divisions • Directly support the logistics operations for Automotive and Comin divisions in Myanmar. • Collaborate with our local partners and make sure processes are correctly defined and implemented. • In collaboration with the Bangkok HO, develop and manage relationships with logistics suppliers focusing on the country and regional needs, based on specific criteria: prices, lead times, service level, flexibility • Provide consistent reports to Logistics Manager (tracking, issues, delivery times, costs etc.) • Working with the group’s divisions, provide sales and tender support in terms of ensuring the correct logistics solutions and pricing and timelines. • Keeps an updated database of freight rates using qualified suppliers, to the major delivery points within the country • Liaise with customers when required by the sales/sales admin and tender teams Technical Responsibilities: (key technical responsibilities of the role) • Ensure that RMA maintains up-to-date knowledge of qualified logistics suppliers in country. • Maintain up-to-date information on customs regulations, import/export processes in country. • Understand the key differences in shipping the range of products provided by RMA (i.e. parts, vehicles, over size equipment etc.) Financial Responsibilities: (key financial responsibilities under the administration of the role) • Ensure that logistics costs are consistently managed and under control. • Check the details logistics expense in supplier’s invoice and respective quotation • Provide forecasts and estimates to Finance/Accounting (cash flow planning for operations) • Keep record of any logistics expense paid for each shipment. HR Responsibilities: • Responsible for developing a logistics team in country, if necessary Travel Requirements: (key travel requirements) • As required. • Travel to Government offices related to FDA, MIC, MoC, Customs etc., • Travel to job sites, warehouse for cargo loading and unloading within Myanmar • Any others areas as required in business
          Senior Software Development Manager - Illumina - Singapore   
Experience in biotech is a plus, as is experience with developing SW to FDA clinical standards. Senior Manager Software....
From Illumina - Fri, 30 Jun 2017 12:44:08 GMT - View all Singapore jobs
          Comment on FDA Chocolate “Salami” by Pat   
Ordering online after eating the last bit that bought while on a trip to Dallas. Couldn't really browse because the store was jammed packed! This is absolutely delicious paired with water or wine!
          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          Sr. Quality Assurance Engineer – DNA Electronics, Inc. – Carlsbad, CA   

5-7 years of experience as a Quality Engineer in an FDA and/or ISO regulated environment in IVD, medical device, or biotech industry....From Indeed - Fri, 30 Jun 2017 22:15:06 GMT - View all Carlsbad, CA jobs

The post Sr. Quality Assurance Engineer – DNA Electronics, Inc. – Carlsbad, CA appeared first on San Diego Biotechnology Network.


          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          ဘုရင္​့​ေနာင္​ကုန္စည္ဒိုင္ကို က်န္းမာေရးဌာန ေ႐ွာင္​တခင္​ စစ္​​ေဆး   


ဘုရင္​့​ေနာင္​ကုန္စည္ဒိုင္ကို က်န္းမာေရးဌာန ေ႐ွာင္​တခင္​ စစ္​​ေဆး
(စုစု ။ Myanmar Now) မိုုးမခ၊ ဇူလိုုင္ ၂ ၊ ၂၀၁၇

ရန္ကုန္ (Myanmar Now) - က်န္းမာေရးဌာနက ရန္ကုန္၊ ဘုရင့္ေနာင္ကုန္စည္ဒိုင္ရိွ ပဲြရံုအမ်ားအျပားကို ဇူလိုင္ ၁ ရက္ေန႔တြင္ ေရွာင္တခင္ ဝင္ေရာက္ၿပီး စားေသာက္ကုန္မ်ဳိးစံုကို စစ္ေဆးခဲ့သည္။

ျမန္​မာႏိုင္​ငံအစားအ​ေသာက္​ႏွင္​့ ​ေဆးဝါးကြပ္​ကဲ​ေရးဦးစီးဌာန(FDA) က စစ္ေဆးေရးအဖဲြ႔ငယ္ ၆ ဖဲြ႔ျဖင့္ ကုန္စည္ဒိုင္အတြင္း သြားေရာက္ၿပီး လက္​ဖက္​စို၊ လက္​ဖက္​ေျခာက္​၊ ဆီ၊ ငါးပိမ်ဳိးစံု၊ င႐ုတ္​သီးမႈန္​႔၊ ပဲမ်ဳိးစံု၊ င႐ုပ္​ဆီ၊ ငါး​ေျခာက္​၊ ပုဇြန္​​ေျခာက္​ အစ႐ွိသည္​့ စား​ေသာက္​ကုန္​မ်ားကို စစ္ေဆးရန္ နမူနာ ဝယ္ယူျခင္း၊ တခ်ဳိ႕ကို ေရြ႕လ်ားဓာတ္ခဲြယာဥ္အတြင္း ခ်က္ခ်င္း စစ္ေဆးျခင္းတို႔ကို ျပဳလုပ္ခဲ့သည္။



ျပည္​သူ႔က်န္​းမာ​ေရးဦးစီးဌာန၊ စားသံုးသူေရးရာဦးစီးဌာန၊ စည္ပင္သာယာေရးဦးစီးဌာန၊ ရဲတပ္ဖဲြ႔တို႔ႏွင့္အတူ သြားေရာက္စစ္ေဆးသည့္ အစီအစဥ္တြင္ စစ္ေဆးခံရသည့္ ကုန္စံုဆိုင္ႏွင့္ ပဲြရံု လုပ္ငန္းရွင္မ်ားကလည္း ပူးေပါင္းေဆာင္ရြက္ခဲ့သည္ကို ေတြ႔ရသည္။

စားေသာက္ကုန္မ်ားတြင္ တားျမစ္ထားေသာ ဆိုးေဆး၊ ဓာတုေဆး ပါဝင္ျခင္း ရိွမရိွ ပံုမွန္စစ္ေဆးေရး လုပ္ငန္းစဥ္အတြက္ ယခင္ကလည္း ဘုရင့္ေနာင္ ကုန္စည္ဒိုင္ရိွ ပဲြရံုတခ်ဳိ႕၊ ရန္ကုန္ရိွ ေစ်းႀကီးမ်ားကို စစ္ေဆးခဲ့ၿပီး ျဖစ္သည္။ အႏၱရာယ္ျဖစ္ေစေသာ အစားအေသာက္ အမ်ဳိးအစား၊ အမွတ္တံဆိပ္မ်ားကို စားသံုးသူတို႔ က်ယ္က်ယ္ျပန္႔ျပန္႔ သိရိွေစရန္ အစုိးရ မီဒီယာမ်ားတြင္ ထုတ္ျပန္လ်က္ရိွသည္။

ဇူလိုင္ ၁ ရက္ေန႔ ဘုရင့္ေနာင္ပဲြရံုစစ္ေဆးေရး အစီအစဥ္တြင္ FDA အရာရိွတို႔က ပဲြရံုလုပ္ငန္းရွင္မ်ားကို ပဲြရံုအတြင္း သန္႔ရွင္းေရး၊ ကုန္စည္ရင္းျမစ္ စသည္တို႔ႏွင့္ ပတ္သက္ၿပီး ပညာေပး တုိက္တြန္းမႈမ်ား ျပဳလုပ္သည္ကို ေတြ႔ရသည္။



က်န္္းမာေရးဌာနက ဝင္ေရာက္စစ္ေဆးရန္ တာဝန္ရိွသည္ကို သေဘာေပါက္ေၾကာင္း ပဲြရံုလုပ္ငန္းရွင္တစ္ဦးျဖစ္ေသာ ေဒၚဝင္းျမင့္က ေျပာသည္။

"ဒီမွာ​ေတာ့ လက္​ဖက္​(အစို)​ေတြကို ဝင္​စစ္​သြားတယ္​။ ဓာတ္​ခြဲခန္​းပို႔ဖို႔အတြက္​လည္​း ​ေရာင္​းလိုက္​ရတယ္​။ ဒီလိုစစ္​တာ​ေတာ့ ဒါပထမဆံုးၾကံဳဖူးတာ​ေပါ့။ အဆင္​​ေျပပါတယ္​ သူတို႔အ​ေနနဲ႔ကလည္​း တာဝန္​အရ ဝင္​စစ္တာပဲေလ" ဟု လက္​ဖက္​ပြဲရံုလုပ္ငန္း လုပ္သက္ ၁ဝ ႏွစ္ရိွၿပီ ျဖစ္ေသာ ​ေဒၚဝင္​းျမင္​့က ​ေျပာသည္​။

ဘုရင့္ေနာင္တြင္ အနံ႔ျပင္း စားေသာက္ကုန္ သိုေလွာင္ျဖန္႔ျဖဴးသည့္ ပဲြရံု အမ်ားအျပား ရိွရာ ဇူလိုင္ ၁ ရက္ေန႔က



FDA ဝင္ေရာက္စစ္ေဆးခဲ့သည့္ ေနရာမ်ားတြင္ ယင္ေကာင္ ကင္းစင္ေနသည္ကို သိသိသာသာ ေတြ႔ရသည္။ ယင္ကင္းစစ္ေစရန္ မည္သို႔ေသာ အစီအမံကို အသံုးျပဳေၾကာင္း မသိရေသးေပ။

ျပည္သူ႔က်န္းမာေရးဌာနႏွင့္ ပူးေပါင္းၿပီး လူထုပညာေပး ေဟာေျပာပြဲမ်ားကိုလည္း နယ္ၿမိဳ႕မ်ားတြင္ အခါအားေလ်ာ္စြာ ျပဳလုပ္ေနသည့္ FDA သည္ ေစ်းကြက္အတြင္း အစားအေသာက္မ်ား အနၱရာယ္ကင္းေစရန္ ထုတ္လုပ္၊ ေရာင္းခ်၊ ျဖန္႔ျဖဴးေသာ လုပ္ငန္းရွင္တို႔ကို တိုက္တြန္းျခင္း၊ စားသံုးသူတို႔ကိုလည္း အခါအားေလ်ာ္စြာ ထုတ္ျပန္ေနေသာ သတင္းမ်ားကို ဂရုတစိုက္ဖတ္ရႈ ေလ့လာျပီး ေဆာင္ရန္ ေရွာင္ရန္မ်ားကို လိုက္နာၾကရန္ လႈံ႔ေဆာ္ျခင္းတို႔ကို ျပဳလုပ္လ်က္ရိွသည္။



တားျမစ္ဆိုးေဆး၊ တားျမစ္ဓာတုေဆး ပါဝင္ေသာ အစားအေသာက္မ်ား စစ္ေဆး ေတြ႔ရိွပါက စားသံုးရန္ မသင့္ေၾကာင္း အမ်ားျပည္သူ သိရိွရန္ ေၾကညာျခင္း၊ ဆက္လက္ထုတ္လုပ္ေရာင္းခ်ျခင္း မျပဳရန္ လုပ္ငန္းရွင္ကို သတိေပးျခင္း ျပဳလုပ္လ်က္ရိွၿပီး ညႊန္ၾကားခ်က္ မလုိက္နာေသာ လုပ္ငန္းရွင္ကို အေရးယူမည္ျဖစ္ေၾကာင္း သိရသည္။

(ဓာတ္ပံုမ်ား - မိုးမခ)









          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          Wild-type RAS metastatic colorectal cancer drug from Amgen gets FDA nod   
Amgen's supplemental biologics license application for Vectibix, or panitumumab, intended to treat patients with wild-type RA -More

          Sorrento's IND for nonopioid pain drug wins FDA approval   
Sorrento Therapeutics' investigational new drug application for resiniferatoxin as a treatment for patients with chronic pain -More

          FDA accepts Teva, Celltrion's BLA for Rituxan biosimilar   
The FDA has accepted Celltrion and Teva Pharmaceutical Industries' biologics license application for CT-P10, a biosimilar to  -More

          Astellas seeks FDA approval of mirabegron in combo with solifenacin succinate   
A supplemental new drug application has been filed by Astellas Pharma for use of mirabegron in combination with solifenacin s -More

          SciBase's melanoma detection device wins FDA approval   
SciBase obtained approval from the FDA for Nevisense, a device designed to facilitate detection of early stages of malignant  -More

          LivaNova's VNS system for younger epilepsy patients approved by FDA   
LivaNova's Vagus Nerve Stimulation Therapy system has been approved by the FDA to treat epilepsy in patients at least 4 years -More

          Introduction to US Tobacco Law and Regulation, Oct. 25, Washington, D.C.   
Gain a comprehensive understanding of FDA law and regulations and how they affect the tobacco industry.  -More

          Celebrity Style At The 2008 CFDA Awards   
There were a LOT of fascinating choices this year, so to save time and space I'm going to limit myself to three gongs: the Weird, the Wonderful and the Whack.


My Whack award goes to Kim Cattrall, mainly because I can't figure out why she pulled her hair into this severe top knot:





Grr, don't you just want to pull it out?


My Wonderful award (and I hate myself for giving it to someone with so little edge) goes to Meredith Melling Burke, who looked really pretty in her Oscar De La Renta dress. Who could resist?








And the Weird? I'm still trying to digest Maggie Gyllenhaal's outfit.










The thing is, I've seen this look millions of times, but only ever on fifty-five-year-old female gallery curators. All she needs is funny red-rimmed spectacles, a limp wrist, middle-age spread (isn't THAT what those blouses are designed to cover?) and a posse of artistic friends who air-kiss and call each other 'dahhhling'.



Check out style.com for more pics.



          Screw Cancer!   

Despite over 5,000 international studies expounding the health benefits of tea, there still appear to be some questions…….not sure how that can happen, but our FDA isn’t happy with natural products. No profits to be made there. Give them pharmaceuticals and they’re giddy. Plants, not so much. A long time … Continue reading

The post Screw Cancer! appeared first on T Ching.


          Listing of Color Additives Exempt From Certification; Spirulina Extract   
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) filed by McCormick & Company, Inc. (McCormick).
          Agency Information Collection Activities; Proposed Collection; Comment Request; Food Safety Survey   
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a voluntary consumer survey entitled ``Food Safety Survey.''
          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          Protection against mosquito vectors Aedes aegypti, Anopheles stephensi and Culex quinquefasciatus using a novel insect repellent, ethyl anthranilate.   

Protection against mosquito vectors Aedes aegypti, Anopheles stephensi and Culex quinquefasciatus using a novel insect repellent, ethyl anthranilate.

Acta Trop. 2017 Jun 27;:

Authors: Islam J, Zaman K, Tyagi V, Duarah S, Dhiman S, Chattopadhyay P

Abstract
Growing concern on the application of synthetic mosquito repellents in the recent years has instigated the identification and development of better alternatives to control different mosquito-borne diseases. In view of above, present investigation evaluates the repellent activity of ethyl anthranilate (EA), a non-toxic, FDA approved volatile food additive against three known mosquito vectors namely, Aedes aegypti, Anopheles stephensi and Culex quinquefasciatus under laboratory conditions following standard protocols. Three concentration levels (2%, 5% and 10% w/v) of EA were tested against all the three selected mosquito species employing K & D module and arm-in-cage method to determine the effective dose (ED50) and complete protection time (CPT), respectively. The repellent activity of EA was further investigated by modified arm-in-cage method to determine the protection over extended spatial ranges against all mosquito species. All behavioural situations were compared with the well-documented repellent N,N-diethylphenyl acetamide (DEPA) as a positive control. The findings demonstrated that EA exhibited significant repellent activity against all the three mosquitoes species. The ED50 values of EA, against Aedes aegypti, Anopheles stephensi and Culex quinquefasciatus were found to be 0.96%, 5.4% and 3.6% w/v, respectively. At the concentration of 10% w/v, it provided CPTs of 60, 60 and 30min, respectively, against Aedes aegypti, Anopheles stephensi and Culex quinquefasciatus mosquitoes. Again in spatial repellency evaluation, EA was found to be extremely effective in repelling all the three tested species of mosquitoes. Ethyl anthranilate provided comparable results to standard repellent DEPA during the study. Results have concluded that the currently evaluated chemical, EA has potential repellent activity against some well established mosquito vectors. The study emphasizes that repellent activity of EA could be exploited for developing effective, eco-friendly, acceptable and safer alternative to the existing harmful repellents for personal protection against different hematophagous mosquito species.

PMID: 28666890 [PubMed - as supplied by publisher]


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AS 10 MAIORES PROPAGANDAS / MENTIRAS DA MEDICINA


A propaganda na medicina moderna é persuasiva. Existem muitos equívocos, omissões, distorções e mentiras em torno da questão da saúde e da medicina.

Muitas são propagadas pagas por aqueles que são os donos dos grandes laboratórios farmacêuticos (ou seja, os Rockefeller e seus lacaios) que estabeleceram a plataforma para a alopatia ou a medicina ocidental para assumir o monopólio e dominar os cuidados com a saúde (ou mais precisamente “gerenciamento do negócio da saúde”) no início do século XX (No artigo “The Flexner Report“: Ele revela como John D. Rockefeller usou a AMA (Associação Médica Americana) para controlar e manipular a medicina ocidental).

Infelizmente, grande parte desta desinformação é propagada involuntária feita por pais bem intencionados, mas mal informados, que querem que seus filhos sejam saudáveis e simplesmente não conseguem ver toda esta propaganda/manipulação da medicina moderna.

Leia também, clique: A Medicina Moderna é Uma Doença

O resultado é uma população que foi treinada/programada para olhar para fora de si em busca da cura, para depender do governo, para depender dos grandes laboratórios nos cuidados de sua saúde e para aceitar inquestionavelmente a opinião de seu médico (ocidental).

Enquanto isto, epidemias de câncer, diabetes e doenças neurodegenerativas (Parkinson, Alzheimer e demência) se espalham em todo os EUA, Austrália e a maioria das nações ocidentais.

Com isso em mente, aqui está a parte 2 de uma coleção das 10 melhores peças da propaganda moderna na área da saúde, clique aqui para a parte 1.

1. Sua Saúde Depende Apenas do Acaso e/ou da Genética.

Peguei vocês ! Quantas pessoas acreditaram nesta mentira ?

Os temas comuns por trás dessas duas crenças são o fatalismo e encontrar uma desculpa para não assumir a responsabilidade pela busca da cura.

Se você está fadado ou destinado a ter doenças, qual é o objetivo de tentar viver de forma saudável ? Se você sucumbe frequentemente à má sorte com sua saúde, por que tentar ?

Você está preso pelos seus “genes ruins”, então qual é o objetivo de lutar ?

É verdade que a genética indica tendências e propensão, mas estas tendências e inclinações precisam ser ativadas.
Resultado de imagem para Dr. Bruce Lipton

Considere o trabalho pioneiro do Dr. Bruce Lipton sobre a epigenética, que afeta a forma como os genes são lidos pelas células e subsequentemente como produzem proteínas.

A epigenética controla os genes. Certas circunstâncias da vida podem fazer com que os genes sejam silenciados ou expressados ao longo do tempo. Em outras palavras, eles podem ser desligados (ficando adormecidos) ou ligados (tornando-se ativos).

A epigenética está em toda a parte. O que você come, onde você mora, com quem você interage, quando você dorme, como você se exercita, mesmo envelhecendo, tudo isto pode eventualmente causar modificações químicas nos genes que vão ativar estes genes ao longo do tempo.

Além disso, em certas doenças como câncer ou Alzheimer, vários genes serão alterados para o estado oposto, distante do estado normal/saudável.

A epigenética nos torna únicos. Mesmo sendo todos humanos, por que alguns de nós têm cabelo loiro ou pele mais escura ?

Por que alguns de nós odeiam o sabor de cogumelos ou berinjelas ? Por que alguns de nós são mais sociáveis do que outros ?

As diferentes combinações de genes que são ativados ou desativados é que torna cada um de nós único. Além disso, existem indícios de que algumas mudanças epigenéticas podem ser herdadas.

O ponto é este: você tem controle sobre quais genes vão se expressar (serem ativados) ou suprimidos (ficarem desativados). Em certo sentido, a vida é frágil.

Ao mesmo tempo, você não é apenas uma pequena mancha de poeira incapaz, que não tem escolha nem controle sobre o que acontece, embora certamente seja adequado para aqueles que acreditam que são incapaz.

2. Você Sempre Pode Ser Curado Por Uma Pílula Mágica Dos Grandes Laboratórios. FALSO.

Este é um corolário do primeiro ponto acima. Se você cair na armadilha de não assumir a responsabilidade pela sua saúde e quero dizer todos os aspectos (físico, mental, emocional e espiritual), então você pode tender a ver o seu corpo como uma máquina ou veículo que precisa ser reparado por um médico/mecânico.

Você também pode tender a acreditar na mentira de que os grandes laboratórios tem uma pílula mágica para tudo, que esta pílula mágica pode resolver todos os seus problemas (sem quaisquer efeitos colaterais) e que, mesmo que os grandes laboratórios não tenham uma pílula mágica agora, eles terão no futuro.

No entanto, é preciso apenas olhar para a contagem chocante de mortes iatrogênicas (óbitos causados por médicos no ocidente e métodos médicos ocidentais, cerca de 225.000 por ano, de acordo com o Dr. Starfield em seu estudo de 2000, o que torna a medicina o 3º principal assassino dos americanos) para perceber que a medicina ocidental está causando muitos danos graves, ao mesmo tempo em que alega curar as pessoas.

Como os grandes laboratórios e a medicina ocidental já criaram a “cura perfeita” ou a “cura para tudo” quando se baseiam em modelos científicos limitados e materialistas que não conseguem entender a natureza holográfica e energética da realidade ?

Além disso, ao comprar e suprimir curas genuínas, os grandes laboratórios mostram que se preocupam mais com “tratar” e “gerenciar” a doença (que é mais lucrativo) do que realmente curá-la (a cura está em outro nível).

3. O Câncer é Uma Doença Terminal e Não é Curável. FALSO.

Quantos sobreviventes de câncer no mundo contradizem esta peça de propaganda/mentira da saúde moderna ?

O número de remédios, curas e protocolos naturais eficazes e bem sucedidos para a cura do câncer estão se acumulando.

Existem tantos agora: laetrile/amygdalin/vitamina B17 (geralmente de amêndoas de damasco), DCA, óleo de cannabis, salvestrols, graviola, tratamento com bicarbonato de arce, injeções intravenosas de bicarbonato de sódio, como indicado pelo italiano Dr. Simoncini, a dieta de Budwig, cloreto de césio, terapia de Gerson, cura Hoxsey, chá essiac, o tratamento anti-neoplaston do Dr. Stanislaw Burzynski e outros.

Um ótimo recurso para aqueles que desejam investigar mais é: cancertutor.com.

Sim, o câncer pode ser assustador, mas é importante saber que existem opções naturais fora da quimioterapia tóxica e radiação, onde a “cura” mata mais do que a própria doença.

4. “Alimentos Saudáveis Para o Coração ™” São Bons Para Seu Coração e Sua Saúde. FALSO.

Nem sempre e muitas vezes eles são atrozes para o seu coração ! Este tipo de propaganda de saúde tóxica é particularmente insidiosa, uma vez que engana as pessoas a pensar que estão fazendo algo de bom para elas mesmas quando compram pacotes com este símbolo.

Alimentos saudáveis para o coração é uma criação da AHA (American Heart Association) que utilizou a pesquisa mal feita do Dr. Ancel Keys, que se tornou proeminente na década de 1950 (esteve até na capa da revista Time) para promover a falsa ideia de que as gorduras saturadas causam doenças cardíacas.

Como fundo desta propaganda/mentira de saúde, leia o artigo “Óleos plásticos vs. gorduras saturadas: Estourando a Propaganda“.

AHA tem provado seguir a mesma linha de desinformação desde então, alegando que como todas as gorduras saturadas são “ruins”, é melhor comer margarina em vez de manteiga.

Isto equivale a dizer que as gorduras hidrogenadas e trans são mais saudáveis do que as gorduras naturais de fontes animais (por exemplo, produtos lácteos) e plantas (coco).

Sim, a AHA também defende uma variedade de frutas e vegetais, grãos integrais e nozes e leguminosas, mas sua informação foi distorcida pelas corporações que a financiam, que denominam de óleos “vegetais” (um nome incorreto deliberadamente que realmente significa óleos industriais/produtos químicos).

Resultado de imagem para crudivorismo benefícios

5. Comer Alimento Cru é Ruim, Insalubre e Perigoso. FALSO.

Não é verdade. A demonização da comida crua faz sentido quando você considera que as forças que controlam o mundo estão empurrando você para longe das formas naturais, suculentas, vibrantes e saudáveis de comer e viver para as sintéticas, secas e mortais.

Quando o medo de um patógeno fica fora de controle, as autoridades governamentais muitas vezes respondem com uma marreta onde era necessário apenas um pente de dente fino. Veja como a Califórnia agora é obrigada a pasteurizar todas as amêndoas por lei.

Sim, comer alimento cru aumenta suas chances (embora ainda sejam pequenas) de ingerir alguma bactéria nociva, mas também aumenta sua probabilidade em um nível elevado de obter mais nutrição e vitalidade de sua comida !

A dieta crua não é a ideal para todos, no entanto, existem poucas dúvidas de que a introdução de mais alimentos crus em sua dieta aumentam sua saúde.

6. O Jejum é Perigoso. FALSO.

Existem muitas maneiras de jejuar, de fazer jejum intermitente (um padrão de alimentação onde você tem ciclo entre os períodos de jejum e comer ao longo(s) do(s) dia(s)) fazendo jejum de 3 dias, 7 dias, 10 dias ou até mais.

Algumas pessoas fazem a limpeza mestre, (consumindo apenas um suco de limão, xarope de pimenta caiena), outras pessoas fazem um jejum rápido com suco de vegetais e ainda outros fazem um jejum rápido bebendo apenas água.

O jejum não é para todos, especialmente crianças ou mulheres grávidas não devem fazer.

É melhor obter orientação de outros que já fizeram e começar devagar, mas as evidências mostram que ao dar ao seu corpo uma parada na digestão, você consegue muitos benefícios para a sua saúde.

Você permite que seu corpo repare e se regenere de uma maneira que não pode fazer se estiver digerindo comida o tempo todo.

7. A Maioria Dos Suplementos São Excelentes Para Sua Saúde. FALSO.

Muitos deles são feitos de vitaminas sintéticas, recheados com enchimentos e contem até mesmo ingredientes de OGM.

É preferível obter todas as suas necessidades nutricionais direto dos alimentos, no entanto, se você vai tomar suplementos, use aqueles que são derivados de ervas, plantas e outras fontes orgânicas.

Os suplementos de cálcio são especialmente perigosos, quando são compostos por fósseis aterrados e podem levar à calcificação.

Muitas pessoas sofrem de calcificação em diversas áreas do corpo. Nos olhos (catarata), boca (placa), ossos (artrite), coração (ataque cardíaco) ou cérebro (acidente vascular cerebral).

Os depósitos de cálcio obstruem o fluxo interno de energia, causam inflamação, calcificam a glândula pineal e podem causar câncer.

Para mais informações sobre as diferenças entre as vitaminas sintéticas e naturais, veja a pesquisa de pessoas como o Dr. Theil:


8. A homeopatia é Charlatanismo e Não Funciona. FALSO.

Mais arrogância que vem da ignorância. A homeopatia baseia-se numa compreensão completamente diferente (e mais profunda) da realidade do que a medicina ocidental puramente racionalista e materialista que não consegue entender que vivemos em um mundo holográfico, onde as formas de pensamento e a energia são forças poderosas que moldam a nossa realidade física inferior.

Veja como funciona a homeopatia em poucas palavras. Existem duas abordagens fundamentais para as doenças.

Você pode seguir a Lei dos Contrários, onde se alguém tiver dor, você fornece uma substância que neutraliza (age como oposto) a esta dor.

Alternativamente, você pode seguir a lei dos similares, onde usa uma substância que produz somente os sintomas em uma pessoa saudável, mas estes mesmos sintomas realmente curam uma pessoa doente. A homeopatia funciona conforme a última lei.

É preciso substâncias que seriam venenos em doses elevadas, que são agitadas e diluídas, agitadas e diluídas, até que a água restante ou o sedimento, contenha apenas uma fração ou impressão do veneno, o suficiente para que quando ingerida estimule o corpo a corrigir o desequilíbrio.

Também requer substâncias saudáveis e não tóxicas que são diluídas da mesma maneira.

A homeopatia reconhece que o corpo é o melhor curador. Ela é projetada para estimular os mecanismos de cura do próprio corpo, em vez de esconder os sintomas ou proporcionar alívio temporário da dor como a alopatia.



Em 1890 nos EUA (antes do Relatório Flexner), cerca de 25% dos médicos eram homeopáticos, incluindo o médico pessoal de John D. Rockefeller e os médicos da Família Real Britânica.

Como David Icke escreve no Eu Fantasma (veja minha revisão do livro aqui):

“A homeopatia é uma técnica de cura ridicularizada pela mídia convencional como qualquer coisa, pelo mesmo motivo, a ignorância. A homeopatia é baseada no fato de que tudo é informação seja uma planta ou uma gota de água.

“O Instituto Aeroespacial de Stuttgart, na Alemanha, é um centro de informação na pesquisa da água. Eles colocaram uma flor em um tanque de água em um experimento e quando ela foi removida, fotografaram as gotículas.

“O que descobriram confirmou duas verdades principais sobre a nossa realidade. A primeira foi que mais uma vez comprovou o princípio holográfico onde cada gota de água continha informações sobre a flor.

“A segunda foi que, mesmo quando a flor” física “foi removida, a informação da flor foi mantida na água. Só tenho uma coisa a dizer. HOMEOPATIA“.

A propaganda diária da saúde moderna insiste que a homeopatia é charlatanismo, no entanto, só descarta a homeopatia devido à pura ignorância ou má intenção.

9. Os Medicamentos Aprovados Pela FDA São Seguros. FALSO.

Nem mesmo está perto de ser verdade. A FDA é comprada pelos grandes laboratórios e funciona como seu cãozinho de estimação e não como um cão de guarda da população.

Você sabia que de acordo com este recente artigo da Natural News, impressionantes 33%, um terço dos medicamentos aprovados pela FDA causaram sérios efeitos colaterais e problemas de saúde tão graves que foram retirados do mercado ?

Como alguém pode confiar no processo de aprovação da FDA com taxas de falha desta magnitude ?

10. As Vacinas São Seguras. FALSO.

De jeito nenhum ! As vacinas estão entre as principais armas da propaganda da saúde moderna atualmente, e existem movimentos em todo o mundo para torná-las obrigatórias, o que é nada menos do que tirania médica ou fascismo médico.

Ano após ano, as vítimas dos danos causados pelas vacinas se acumulam, sejam pessoas que sofrem de febre, infertilidade, paralisia, dano cerebral e morte.

Nos EUA, os grandes laboratórios conseguiram a habilidade legal e política de aprovar uma lei (através de suborno) que os isenta de serem processados em tribunais normais por danos causados pelas vacinas.

Enquanto isto, o sistema que foi criado (Vaccine Injury Compensation Program [VICP]) é quase um tribunal que favorece os fabricantes de vacinas. Para citar um outro artigo da Natural News,

“…o governo pagou mais de US $ 3 bilhões em prêmios e honorários legais para famílias e pessoas que foram afetadas por danos causados pelas vacinas somente entre os anos de 1989 e 2015 nos EUA”.

“No total, 3.937 casos resultaram na concessão de compensação financeira através do Programa de Compensação de Acidentes de Vacina (VICP). E esses são apenas aqueles que conseguiram convencer o tribunal de que uma vacina danificou seu filho ou eles mesmos. Cerca de 10.000 pessoas tiveram seus casos rejeitados pelo tribunal.

Robert Moxley, um ex-advogado de vacinas, escreve: “Desde a aprovação da legislação em 1986, o processo foi manipulado, um passo de cada vez, a favor do complexo industrial de vacinas “O VICP protege a Indústria da vacina, em vez dos humanos prejudicados por suas inoculações”.

“As lesões continuam a acontecer e os prêmios continuam a ser pagos, praticamente em segredo”, ele afirma. “Os casos de lesão de vacina continuaram a se acumular, o governo ao invés de responsabilizar os fabricantes, escolheu revisar seus padrões para reivindicações sobre lesões causadas pelas vacinas. Tornando ainda mais difícil a reivindicação passar pelo sistema”.

Conclusão: Propaganda da Saúde
Tal como acontece com a geopolítica, existe uma grande propaganda da saúde moderna ao nosso redor. Neste caso, o que você não sabe pode matá-lo.

É de vital importância educar-se sobre saúde, nutrição, curas naturais, remédios, medicamentos e protocolos, os pontos fortes e fracos de diferentes sistemas médicos e a natureza dos grandes laboratórios.

Ainda mais importante é a sua mentalidade; Sim, é ótimo cortar a propaganda da saúde, mas o melhor é assumir total responsabilidade pelo seu estado de saúde.

©Makia Freeman



          Feature Requests (FFA Win) - http://www.burnfatin4days.com/testo-rampage/   
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          1mW Hades系列蓝色激光笔   

1mW Hades系列蓝色激光笔是最独特的一支激光笔,能够在黑暗中发出诱人的宝石般明亮的蓝色激光光束。低功率460nm蓝色激光笔是一款适用于各种场合的指示激光。这款专业的激光笔在指示应用中发挥着重要的作用。

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          re: Paying Respect to Dr. Kummerow   

I, too, am grateful to titans like Dr. Kummerow who work tirelessly to bring the truth of science to light for all our benefit. My one regret is his willingness to cede authority to the FDA as arbiter of  truth for the American people. The FDA is a corrupt, predatory organization which violates our rights and harms us in ways difficult to discern. Please google Amish farmer, Sam Girod of Kentucky, to see their latest outrage against innocent individuals. Rather, I would have preferred Dr. Kummerow to go directly to the people and to all the private organizations who work in the field of nutrition and health to spread the word. We need to do an end run around the FDA and take our health in our own hands. We cannot wait for them to pass laws to protect us. One great example is their unholy relationship with Monsanto and their deadly but legal sale of Roundup. But I'm sure the list is long of many more companies who "pay" for FDA approval and who then provide products that are actually harmful to trusting Americans.


          Edible Maple Leaves - Dark Burnt Orange/Red 1 dozen - Cake & Cupcake toppers - Food Decoration by SugarRobot   

7.95 USD

These lifelike leaves are completely edible! They are a gorgeous deep burt orange-red color.

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Each leaf has been brushed with a coat of organic vanilla flavoring.

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Although there are no nuts in the ingredients - Sugar Robot's production facilities are NOT a tree nut free environment


          Stocks to watch next week   

Notable earnings reports : PriceSmart on July 5, Rand Logistics on July 5, Yum China on July 5. IPO quiet period expirations : Smart Global Holdings on July 3, ShotSpotter on July 3, Appian Corp on July 4, WideOpenWest on July 4. Secondary offering lockup expirations : Agios Pharmaceuticals on July 3, RSP Permian on July 3, Quotient on July 5, Synacor on July 5, Everbridge on July 5, Catalyst Biosciences on July 6, Codexis on July 6, Hyatt Hotels on July 7. Special shareholder meetings : Conyers Park Acquisition on July 5, Galena Biopharma on July 6, Alere on July 7. M&A watch : Expected closing for the merger between General Electric and Baker Hughes on July 3. Monthly sales update : Costco on July 5, L Brands on July 6, Buckle on July 6, Fred's on July 6, Cato on July 6. FDA watch : Pfizer present briefing documents on July 7 ahead of an Oncologic Drugs Advisory Committee meeting on ... (more)


          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          Pico Bong Honi   


One of the featured toys this week at Shelly’s Toy Box is the Honi. An amazing 12 different vibration patterns can be enjoyed over multiple speeds, providing a spice-based cliché concerning variety and life! With an exciting array of possibilities Honi’s 2-button interface is easy to operate and totally user-friendly, ensuring nothing gets between you and a good time. Not only is the Honi easy to clean, but it’s also the ideal toy for the bath, shower, swimming pool – even a babbling brook, if that’s your thing. Completely waterproof and not only is the motor strong enough to knock your socks off, but it does so in the quietest way. Perfect for those with nosy roommates. All this plus the Honi and all of Pico Bong Toys are made with the best FDA approved materials and come with a 1 Year warranty. 

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          Senior Software Development Manager - Illumina - Singapore   
Experience in biotech is a plus, as is experience with developing SW to FDA clinical standards. Senior Manager Software....
From Illumina - Fri, 30 Jun 2017 12:44:08 GMT - View all Singapore jobs
          Peristaltic pump   
DC24V peristaltic pump * 500 ml/min flow rate * 40psi output liquid pressure * 1/4" PharMed peristaltic tube with FDA approval * 1/4" barbed connector for external connection * DC brush motor * ...Honlite Industrial Co., Ltd.
          Reader recommends magic mushrooms to prevent cluster headaches   
Joe and Teresa Graedon caution that the FDA considers psilocybin a Schedule I drug, meaning that it has no currently accepted medical use. Meanwhile, other readers have questions about thyroid and diabetes meds. Reported by Seattle Times 4 hours ago.
          Senior Software Development Manager - Illumina - Singapore   
Experience in biotech is a plus, as is experience with developing SW to FDA clinical standards. Senior Manager Software....
From Illumina - Fri, 30 Jun 2017 12:44:08 GMT - View all Singapore jobs
          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          FIFA yaja kuchunguza sakata la Malinzi uchaguzi hatihati   
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          Brain zap helps spine-damaged rats walk   

Applying electrical pulses deep in the brain improves speed and endurance

On the Scene

Editor’s Note: Science News intern Tanya Lewis is attending the neuroscience meeting in New Orleans on a travel award from the Society for Neuroscience.

NEW ORLEANS – Stimulating the brains of rats with spinal cord injury improves their ability to walk, researchers reported October 15 at the annual meeting of the Society for Neuroscience. The findings may suggest ways to treat spinal injuries in humans.

Known as deep brain stimulation, the approach has already been shown to be an effective treatment for easing the movement symptoms of Parkinson’s disease. It involves surgically implanting a kind of pacemaker for the brain that delivers small electrical pulses to hard-to-reach brain areas. For the rats, the targeted area was a region of the midbrain that, when activated, sends commands to the spinal cord that enable walking.

Rats in the study, by Brian Noga, Ian Hentall and colleagues at the University of Miami’s Miller School of Medicine, were given mild, moderate or severe bruises that severed some nerves in the spinal cord and left others intact. Such damage is common in human spinal cord injuries, of which about 60 percent are this “incomplete” variety. Over a 10-week period, researchers monitored the injured rats as they walked on a treadmill.

While receiving deep brain stimulation, rats showed a noticeable improvement in treadmill walking speed and endurance. The biggest improvements were among rats that could fully support themselves, but some unsupported rats did exhibit stepping movements. The results suggest, counter to what has long been thought, that walking ability can be enhanced even without a fully intact spinal cord, Noga reported at the meeting.

Scientists are still a long way from applying the treatment in humans. But unlike some other experimental treatments for spinal cord injury, deep brain stimulation has already cleared the hurdle of FDA approval for use in movement disorders.

Deep brain stimulation is not the only form of electrical stimulation that could help restore movement after a spinal cord injury. Other research involves directly zapping the spinal cord (SN: 6/30/12, p. 5) or stimulating nerves that control muscles in the arms and legs.


          Business Game Changers Radio with Sarah Westall: The Miracle of Adult Human Stem Cells - Is the FDA Blocking Safe and Effective Treatments for Suffering Americans?   
EpisodeThe FDA has been scrutinized for blocking promising treatments and research for many chronic diseases and conditions. It has also been accused of being significantly behind the rest of the developed world at allowing new treatments into the U.S. market. On the other hand, they claim that their work is to protect the American people and any delays are to protect people. But who to believe? The truth is more complicated then it appears and an easy answer does not exist. The FDA does keep bad ...
          (USA-VA-Portsmouth) Clinical Research Coordinator   
Job Description **Summary** : R esponsible for providing research coordinator support for Institutional Review Board (IRB) and Institutional Animal Care and Utilization Committee (IACUC) - approved research protocols. This position organizationally supports the Department Head of the CID, Directorate for Professional Education, NMCP. The individual will coordinate activities of NMCP's Combat Trauma Research Group (CTRG), including human clinical research and animal research in conjunction with the group's Director and Principal Investigators (PI) of approved research protocols. + Responsible for coordinating the research activities of assigned IRB and IACUC-approved study protocols. Specific protocols that require the CRC's support will be determined by the Department Head of CID in consultation with the PI. Protocols will include both pediatric and adult patients + Supports the Department Head of CID and is accountable for research matters to the PIs of each research protocol. Work is evaluated by observation and outcomes for effectiveness of operations and compliance with medical requirements and professional standards in terms of quality and appropriateness. + Provides support to the Department Head of CID and the Principal Investigators of each protocol in accordance with written policies and procedures as set forth in Title 21 of the Code of Federal Regulations, NMCP and Bureau of Medicine & Surgery (BUMED) instructions. Independent judgment is exercised to determine appropriate action and priorities in the performance of duties. + Knowledge of complex regulations, policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP), International Council on Harmonisation (ICH) regulations and Investigational New Drug (IND) requirements. + Ensures all studies performed are in accordance with the approved protocol and applicable local, state, and federal regulations. + Works closely with the Senior Research Technician/Supply Purchase officer in ordering study materials, equipment and/or research animals as specified in the research protocol in accordance with CID IACUC policies and animal facility standard operating procedures. + Coordinate with Principal Investigator to ensure all resources are available as necessary to meet research timelines. + Personal contacts are with patients, their families and/or significant others, providers, clinical nurses, nursing department head, corps staff, respiratory staff and clerical staff. The CRC will also have frequent contacts with research personnel from government agencies, granting agencies and industry sponsors. Contacts will be for the purpose of consultation, reporting, exchange of information, orientation, teaching, support for the performance of duties, and to elicit positive behavioral response such as guiding patients through a research protocol. Shall report data on research patients in accordance with IRB-approved protocols and applicable regulations. + Recruit and screen patients using protocol inclusion/exclusion criteria. Refer eligible patients to the PI for final evaluation. + Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented. + Provide education to patients on compliance, possible side effects, drug interactions and the importance of contacting the coordinator. + Coordinate the performance of phlebotomies, electrocardiograms, initiate intravenous infusions, vital signs, specimen collection and other procedures as required by the protocol. + Will be adept in the use of managerial skills, communication skills and leadership skills as the coordinator of complex human and animal research protocols. + Must be proficient in appointment booking, coordinate laboratory studies, x-rays, and other tests. + Assign appropriate patient randomization number per protocol design. + In collaboration with the Research Pharmacist, ensure that drugs are correctly dispensed as per protocol. + Maintain accurate documentation record of drugs received. + Process and prepare specimens for lab analysis and shipping. + Observe universal precautions and OSHA standards when processing or handling specimens. + Obtain laboratory results and consult with the PI for follow-up care. + Collect data in a timely and accurate manner and submit information to coordinating centers as required. + Report adverse events to governing agencies and sponsors as required by protocol and regulations. + Evaluate compliance of research subject and complete documentation of status and progress. + Maintain detailed documentation of the research study as required by the protocol and the Investigator's File Binder/Regulatory Binder. + Prepare reports and other correspondence regarding the research protocol for IACUC, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol. + Interact on a regular basis with the PI and Research Scientist regarding the conduct of the research study. + If properly certified (LVT-licensed) may extract blood or place bandages on animal subjects, assist with the restraint and handling of laboratory animals, surgical preparation, induction and maintenance of anesthesia, operation of physiologic monitoring equipment, collection and recording of anesthetic and experimental data and parameters. + Assists with amendment creation and review. + Attend conferences and other meetings as required by the protocol, the PI or sponsoring agency. + Work is performed in ambulatory care spaces inpatient wards, and the vivarium, all of which present some risk of exposure to infectious disease, for which gloves, masks, or gowns provided by the government entity may be required for safety reasons. Education + A Bachelor's Degree or higher is required. Candidates with evidence of post-baccalaureate advanced education to include a Master's Degree or certification as a Registered Nurse may be given preference during the technical evaluation. + A BS/AAS is preferred in animal science, zoological, biological sciences, veterinary technology specifically related to Laboratory Animal Research required. Bachelor with certification as ALAT, LAT or LATG with AALAS may be given preference during the technical evaluation. Qualifications + Must be a US Citizen. + 2-5 years of related experience in scientific research and analysis. + A minimum of two years' experience coordinating research protocols (four years preferred) as a certified research coordinator **OR** certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA). + A minimum of two years' experience coordinating animal research protocols OR certification as a Research Animal Coordinator (RAC). RAC certification may be given preference during the technical evaluation. + Working knowledge of PHS, OLAW, AWA, USDA, Guide and AAALAC + Working knowledge of IACUC rules and regulations. + Experience with submission of protocol amendments + Experience with exotics, small animal ruminants, and large animal models. + Working knowledge of U.S. Federal government regulations regarding the conduct of human clinical research. + Knowledge of complex regulations, policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP), International Council on Harmonisation (ICH) regulations and Investigational New Drug (IND) requirements + Ability to communicate effectively in written and verbal modes and to teach in formal and informal settings. + Skills in counseling, guidance, and maintaining interpersonal relationships. + Will complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and NMCP research integrity training within one month from start date and additional protocol specific training as required. As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/Affirmative Action Employer - Minorities/Females/Protected Veterans/Individuals with Disabilities.
          (USA-VA-Portsmouth) Clinical Research Coordinator   
Job Description **Summary** : R esponsible for providing research coordinator support for Institutional Review Board (IRB) and Institutional Animal Care and Utilization Committee (IACUC) - approved research protocols. This position organizationally supports the Department Head of the CID, Directorate for Professional Education, NMCP. The individual will coordinate activities of NMCP's Combat Trauma Research Group (CTRG), including human clinical research and animal research in conjunction with the group's Director and Principal Investigators (PI) of approved research protocols. + Responsible for coordinating the research activities of assigned IRB and IACUC-approved study protocols. Specific protocols that require the CRC's support will be determined by the Department Head of CID in consultation with the PI. Protocols will include both pediatric and adult patients + Supports the Department Head of CID and is accountable for research matters to the PIs of each research protocol. Work is evaluated by observation and outcomes for effectiveness of operations and compliance with medical requirements and professional standards in terms of quality and appropriateness. + Provides support to the Department Head of CID and the Principal Investigators of each protocol in accordance with written policies and procedures as set forth in Title 21 of the Code of Federal Regulations, NMCP and Bureau of Medicine & Surgery (BUMED) instructions. Independent judgment is exercised to determine appropriate action and priorities in the performance of duties. + Knowledge of complex regulations, policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP), International Council on Harmonisation (ICH) regulations and Investigational New Drug (IND) requirements. + Ensures all studies performed are in accordance with the approved protocol and applicable local, state, and federal regulations. + Works closely with the Senior Research Technician/Supply Purchase officer in ordering study materials, equipment and/or research animals as specified in the research protocol in accordance with CID IACUC policies and animal facility standard operating procedures. + Coordinate with Principal Investigator to ensure all resources are available as necessary to meet research timelines. + Personal contacts are with patients, their families and/or significant others, providers, clinical nurses, nursing department head, corps staff, respiratory staff and clerical staff. The CRC will also have frequent contacts with research personnel from government agencies, granting agencies and industry sponsors. Contacts will be for the purpose of consultation, reporting, exchange of information, orientation, teaching, support for the performance of duties, and to elicit positive behavioral response such as guiding patients through a research protocol. Shall report data on research patients in accordance with IRB-approved protocols and applicable regulations. + Recruit and screen patients using protocol inclusion/exclusion criteria. Refer eligible patients to the PI for final evaluation. + Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented. + Provide education to patients on compliance, possible side effects, drug interactions and the importance of contacting the coordinator. + Coordinate the performance of phlebotomies, electrocardiograms, initiate intravenous infusions, vital signs, specimen collection and other procedures as required by the protocol. + Will be adept in the use of managerial skills, communication skills and leadership skills as the coordinator of complex human and animal research protocols. + Must be proficient in appointment booking, coordinate laboratory studies, x-rays, and other tests. + Assign appropriate patient randomization number per protocol design. + In collaboration with the Research Pharmacist, ensure that drugs are correctly dispensed as per protocol. + Maintain accurate documentation record of drugs received. + Process and prepare specimens for lab analysis and shipping. + Observe universal precautions and OSHA standards when processing or handling specimens. + Obtain laboratory results and consult with the PI for follow-up care. + Collect data in a timely and accurate manner and submit information to coordinating centers as required. + Report adverse events to governing agencies and sponsors as required by protocol and regulations. + Evaluate compliance of research subject and complete documentation of status and progress. + Maintain detailed documentation of the research study as required by the protocol and the Investigator's File Binder/Regulatory Binder. + Prepare reports and other correspondence regarding the research protocol for IACUC, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol. + Interact on a regular basis with the PI and Research Scientist regarding the conduct of the research study. + If properly certified (LVT-licensed) may extract blood or place bandages on animal subjects, assist with the restraint and handling of laboratory animals, surgical preparation, induction and maintenance of anesthesia, operation of physiologic monitoring equipment, collection and recording of anesthetic and experimental data and parameters. + Assists with amendment creation and review. + Attend conferences and other meetings as required by the protocol, the PI or sponsoring agency. + Work is performed in ambulatory care spaces inpatient wards, and the vivarium, all of which present some risk of exposure to infectious disease, for which gloves, masks, or gowns provided by the government entity may be required for safety reasons . Education + A Bachelor's Degree or higher is required. Candidates with evidence of post-baccalaureate advanced education to include a Master's Degree or certification as a Registered Nurse may be given preference during the technical evaluation. + A BS/AAS is preferred in animal science, zoological, biological sciences, veterinary technology specifically related to Laboratory Animal Research required. Bachelor with certification as ALAT, LAT or LATG with AALAS may be given preference during the technical evaluation. Qualifications + Must be a US Citizen. + 2-5 years of related experience in scientific research and analysis. + A minimum of two years' experience coordinating research protocols (four years preferred) as a certified research coordinator **OR** certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA). + A minimum of two years' experience coordinating animal research protocols OR certification as a Research Animal Coordinator (RAC). RAC certification may be given preference during the technical evaluation. + Working knowledge of PHS, OLAW, AWA, USDA, Guide and AAALAC + Working knowledge of IACUC rules and regulations. + Experience with submission of protocol amendments + Experience with exotics, small animal ruminants, and large animal models. + Working knowledge of U.S. Federal government regulations regarding the conduct of human clinical research. + Knowledge of complex regulations, policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP), International Council on Harmonisation (ICH) regulations and Investigational New Drug (IND) requirements + Ability to communicate effectively in written and verbal modes and to teach in formal and informal settings. + Skills in counseling, guidance, and maintaining interpersonal relationships. + Will complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and NMCP research integrity training within one month from start date and additional protocol specific training as required. As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/Affirmative Action Employer - Minorities/Females/Protected Veterans/Individuals with Disabilities.
          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          Edible Ombre Monarch Butterflies - Cake and Cupcake Decorations - Food Decorations - Edible Butterflies by SugarRobot   

7.95 USD

*Please read shipping & policies info before you place your order for estimated shipping and delivery times.

-You will receive 12 Edible Butterflies in the Ombré color of your choice

-Wing span is approx. 2.5 inches.

-Precut and Ready to Use

-Made of wafer paper (potato starch, vegetable oil, water) and food color. FDA approved print.
Each edible butterfly has been brushed with a coat of organic vanilla flavoring.

-Use a dab of regular frosting or corn syrup to adhere to most food items, wine glasses, and serving dishes. Fold up the wings on either side of the body for a fluttering effect.

-Use within 4 months of receiving them. Store in the packaging they arrive in. Each item is sealed for optimum freshness. Do not refrigerate.

★★★★ All Items are Gluten Free and 100% Vegan ★★★★
Although there are no nuts in the ingredients - Sugar Robot's production facilities are NOT a tree nut free environment

Edible Butterflies © are Copyright protected.....Any persons found in violation will be sentenced to the basement and fed to our Copyright Monster (grrrr) - no really, they are protected


          Sunovion Announces FDA Acceptance for Review of Supplemental New Drug Application for Latuda® (lurasidone HCI) for the Treatment of Bipolar Depression in Children and Adolescents   
...been shown to result in significant impairment in work, family and social function, 12,13 and are associated with increased risk of suicide and direct and indirect health care costs. 14,15 About LATUDA LATUDA is used to treat patients with ...

          Sunovion Announces FDA Acceptance for Review of New Drug Application Resubmission for SUN-101/eFlow® (glycopyrrolate) for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)   
...is due to airway and/or lung abnormalities usually caused by significant exposure to toxic particles or gases. The main risk factor for COPD is tobacco smoking, but other environmental exposures may contribute. 1  Approximately 15.7 million adults in the ...

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          Teva's (TEVA) Filing for Biosimilar Rituxan Accepted by FDA   
Teva Pharmaceutical Industries Ltd TEVA and Korean partner Celltrion Inc announced that the FDA has accepted for review their Biologics License Application BLA for CT P10 a proposed biosimilar to Roche Holding AG s RHHBY Rituxan rituximab The regulatory action by the FDA is expected
          Senior Software Development Manager - Illumina - Singapore   
Experience in biotech is a plus, as is experience with developing SW to FDA clinical standards. Senior Manager Software....
From Illumina - Fri, 30 Jun 2017 12:44:08 GMT - View all Singapore jobs
          (USA-NJ) Vice President, Clinical Operations   
The pioneer of independent ethical review, **WIRB-Copernicus Group® (WCG),**continues to drive ingenuity in the clinical research space. Today, WCG’s solutions are built upon the foundation of ethical review, but have grown to include a suite of complementary services and technologies that expand the capabilities of the modern research professional. WCG delivers transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those who perform clinical trials. # Position Summary: The **Vice President of Clinical Operations** is responsible for Clinical Operations with a focus on the oversight of resourcing, developing, training, and managing a successful global clinical operations team. Responsibilities also include the oversight, management, and delivery of clinical development programs in support of all the strategic teams. This person will be responsible for the operational delivery of services to WCG clients in the conduct of clinical trials. They will also act as the Line Manager for all staff within the assigned teams and manage/oversee the financial and budgetary aspects of their department. # Essential Duties/Responsibilities: * Responsible for the oversight, management, and delivery of clinical services in support of the corporate vision. * Act as the Line Manager for all staff within the assigned teams and manage/oversee the financial and budgetary aspects of the clinical department. * Integrate multiple modular services into a seamless delivery experience from the client perspective. * Collaborate with the Business Development team to forecast and align internal capacities and capabilities to market demands. * Manage budgets, staffing, and utilization levels for the overall project portfolio to ensure profitability of the portfolio as a whole as well as that of individual projects. * Manage relationships with key stakeholders (investigative sites in addition to biopharma clients) to ensure smooth implementation and high satisfaction. * Promote internal collaboration to provide high-quality and innovative solutions. * Lead and mentor Clinical Managers and support successful internal training and its implementation. * Provide strategic direction to meet project timelines/enrollment goals, data quality, sponsor objectives, and contractual obligations for Clinical Operations. * In collaboration with QA, lead the creation, review, and update of the clinical services’ SOPs. * Ensure that Global and Local SOPs, ICH GCP Guidelines, and FDA Regulations are rigidly implemented in clinical trials. * Maintain ongoing awareness of developments with the clinical research field. # Education Requirements: * Bachelor’s degree in related field required. Life sciences and/or medical or nursing background preferred. * PMP certification preferred. # Qualifications/Experience Requirements: * Minimum 15 years’ relevant experience in a life sciences, biopharma, or CRO organization is preferred. * Demonstrated progressive experience at key operational levels within a CRO environment is preferred. * Ability to think strategically at the executive level, implement change, incorporate innovation, and implement strategies throughout all levels of the organization. * Exceptional team leadership skills to include the ability to effectively mentor, motivate, and empower team members. * Strong leadership skills including financial management, problem solving, and development of employees. * Must have a proven track record in building internal capability. * Prior experience in startup or acquisition integration would be helpful. * Must have excellent written and oral communication skills, organizational skills, interpersonal skills, and ability to work with people from a variety of disciplinary, cultural, and linguistic backgrounds. We encourage you to visit us at www.wcgclinical.com to learn more about our organization and WIRB-Copernicus Group’s mission of improving the quality of human health. *We are an Equal Opportunity Employer. Minorities, females, veterans, and individuals with disabilities are encouraged to apply. * This is a full time-exempt position
          (USA-WA-Puyallup) Regulatory Board Chair/Vice Chair   
For more than 45 years, **Western Institutional Review Board® (WIRB)**, a member of the WIRB-Copernicus Group, has been at the forefront of protecting the rights and welfare of human subjects during all phases of clinical trials. Recognized as the gold standard of human subject protection, WIRB is the trusted partner to over 1,000 institutions in the United States alone, ranging from small community hospitals and research sites to large academic medical centers and universities. Our distinguished staff of full-time physicians, Certified IRB Professionals, lawyers, and research professionals delivers unparalleled review quality to ensure that human research studies withstand scrutiny around the world. **We're looking for a dynamic and motivated professional to join our mission of protecting human research subjects as our Regulatory Chair/Vice Chair at our Puyallup, Washington location. In this position, you will provide regulatory assistance to clients, the company, the Board, and staff to ensure compliance with governing rules and regulations. We offer competitive compensation and benefit programs.** # Essential Duties/Responsibilities: * Chair Board meetings to ensure compliance with federal and state laws and company policies and procedures; facilitate discussion from Board members; provide ethical and legal support and advice to Board members. * Assist in resolution of disagreements between Board members. * Analyze and present protocols and other agenda items at Board meetings to facilitate informed decision making and to set standards and role model effective presentation and discussion for all Board members. * Analyze research submissions, identify problems and issues, collect additional information or request corrections, and draft memoranda. * Research, draft, and present reports to the Board on a wide range of topics, including but not limited to, investigator misconduct, site visits, FDA and sponsor audits of investigators and others, issues involving human subjects, sponsors, and institutions. * Convey the Board’s concerns with the research submission by composing written correspondence to investigators and sponsors. This may include requesting additional information and providing the rationale for required changes. * Identify and assist in the resolution of problematic review items through interaction with investigators and other IRB clients. * Advise clients of applicable laws and regulations pertaining to human subject research, both orally and in writing. Provide guidance to help resolve ethical and regulatory issues and difficulties. * Research state, federal, and international law and regulations pertaining to human subject safety and research-related issues. * Review literature and other materials to keep abreast of developments in the regulatory, legal, and ethical arenas. # Education Requirements: * Juris Doctor or Master’s degree preferred. * Bachelor’s degree required and three years' related experience and/or training, or equivalent combination of education and experience. # Qualifications/Experience Requirements: * Experience in regulatory affairs or IRB, US Good Clinical Practice (GCP), Code of Federal Regulations (CFR) Titles 21 and 45, and International Conference of Harmonisation (ICH) Guidelines, and other applicable regulations desired. * Able to Chair Board meeting; can effectively present information to a diverse group of professionals. * Knowledge of MS Word, MS Excel, MS Outlook, and MS Windows. # Management Responsibilities: * None We encourage you to visit us at www.wcgclinical.com to learn more about our entire organization and WIRB-Copernicus Group’s mission of improving the quality of human health. *We are an Equal Opportunity Employer. Minorities, females, veterans, and individuals with disabilities are encouraged to apply. * This is a full time-exempt position
          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          z1408: Витамин В17 убивает раковые клетки   
b17 (680x460, 64Kb)
Этот витамин убивает раковые клетки
На протяжении более 40 лет, ученым известен этот природный комплекс, который убивает раковые клетки. И все же, вы, вероятно, никогда о таком не слышали.
Профилактика рака — «неизвестный» известный витамин В17
Витамин В17 стал предметом острых споров и открытой войны еще 20 лет назад, когда некоторые из ведущих ученых мира объявили, что при его употреблении человек на 100 процентов гарантирован от процесса развития рака и в большинстве случаев витамин убивает уже существующий рак.

Витамин В17 стал предметом острых споров и открытой войны еще 20 лет назад, когда некоторые из ведущих ученых мира объявили, что при его употреблении человек на 100 процентов гарантирован от процесса развития рака и в большинстве случаев витамин убивает уже существующий рак.

Фармацевтические компании немедленно набросились на это заявление и потребовали пересмотра результатов анализа. Результаты исследования FDA (Администрации Пищевых Продуктов и Лекарств) были подтасованы — об этом можно прочитать в книге Эдварда Д. Гриффина «Мир без рака». («World Without Cancer»).

Транснациональные фармацевтические компании совместно с медицинским истеблишментом США заставили FDA объявить незаконным продажу «сырых» абрикосовых косточек или Витамина В17 с приложенной к ним информацией об их антираковом эффекте.

Фармацевтические компании проводят исследования только тех химикалий, которые они изобретают; таким образом, если лекарство утверждено, у них появляются эксклюзивные права на его продажу. И они никогда не пойдут на то, чтобы провести исследования на простой еде, которая не может быть ими запатентована и может продаваться в любом супермаркете.

Эта страница предлагает краткую версию фактов, которые размещены в книге «Мир без рака» Эдварда Д. Гриффина. Книга «Мир Без Рака» раскрывает множество информации об исследованиях в области рака, которые были приостановлены, и о крупных ученых, которые были арестованы, когда они начали сообщать другим правду о витамине. Она содержит отчет об испытаниях, проводившихся на Amygdalin (витамине B17, laetrile) в известном раковом институте, Sloan Kettering, Нью-Йорк, США, и были закрыты.
Витамин В17, также известный как Лаэтрил и Амигдалин, был найден в большинстве фруктовых косточек, в частности, абрикосовых. Семя абрикоса было объявлено лекарством от всех известных раков еще 35 лет назад.

Еще с большей уверенностью ученые заявили, что если эти семена входят в ежедневную диету человека, раковые клетки у него никогда не будут развиваться, так же как, например, человек никогда не заболеет цингой, если он съедает в день хотя бы один апельсин, или же пеллагрой, если в его рацион входит Витамин В.

Большинство людей с раковыми опухолями в теле, которые поели абрикосовых косточек или Витамин В17 в форме таблеток, почти избавились от них. И хотя больные раком избавились от рака, проблемы с повреждением жизненных органов у них остались. Для их регенерации потребуются уже другие травы и лекарства — и это уже другой вопрос. Конечно, когда тело человека насквозь изъедено раком, даже самый сильный экстракт Витамина В17 может только продлить ему жизнь во много раз больше, чем химиотерапия. Однако, во многих случаях сильная доза инъекции Лаэтрила во много раз снижает боль.
Витамин B-17 найден в большинстве плодовых семян. Его компоненты дают нам все необходимое, чтобы жить без рака. Семена — для каждого, чтобы их есть. Не ждите, когда у вас появится рак, чтобы начать их включать в свою диету.

Витамин B17 найден в семенах яблока, персика, вишни, виноградов, и абрикоса. Он обнаружен в некоторых бобовых и многих травах типа пшеничного злака. Жесткое ядро в глубине абрикоса находится там совсем не для того, чтобы его выбрасывать.

Фактически, эта плотная деревянная оболочка защищает один из наиболее важных пищевых продуктов на земле, известных человеку. Это — одна из главных составляющих диеты народов таких культур как индейцы. В народах этих культур не наблюдалось ни одного случая ракового заболевания, пока их диета содержала в себе традиционные пищевые продукты!
Мы не должны делать семена основой нашего питательного рациона, но мы нуждаемся в эквиваленте приблизительно семи абрикосовых семян в сутки. Это количество гарантирует нашу свободу от рака. Другие пищевые продукты, которые содержат витамин B-17, таковы: жесткий миндаль, просо, бобовые и другие. (Жесткое миндальное дерево также было запрещено в США несколько лет назад.)

Семена абрикоса имеют самое высокое содержание B-17 на земле. Их нужно разжевывать, несмотря на их горечь, потому что они необходимы в нашей диете. Они могут быть добавлены к любому пищевому продукту. Их можно дробить и глотать с чайной ложкой меда. В качестве профилактики, доктор Кребс (ученый, обнаруживший B-17) утверждает, что около 7 семян абрикоса в сутки гарантирует человеку защиту от рака на всю жизнь. Одна или две таблетки B-17 (100 мг) в сутки — наиболее приемлемая дозировка. Магазины Здорового Питания в США больше не продают семена абрикоса из-за давления FDA, которое несколько лет устроило рейды по этим магазинам на предмет наличия витамина B17 и семян абрикоса.

Почти во всех случаях рака, когда B-17 принимается в больших дозах, раковые опухолистягиваются. Теперь перед каждым, кто лечится химиотерапией, встает выбор: прекратить ее немедленно или же продолжать ее, мучительно гадая о ее действенности. Тех, кто продолжают свою химиотерапию, ждет достаточно грустный результат. Мы понимаем, что, как только индивидуум попал в вакуумный цикл химиотерапии, облучения и хирургии, очень трудно вытащить его из этого порочного круга (властные медучреждения, престижные доктора и больницы). Сотни людей принимают неправильные решения, потому что все еще надеются, что их опухоль исчезнет (в это обязательно нужно поверить). Да, она на время стягивается после химиотерапии, но вскоре начинает снова разрастаться согласно своему естественному процессу.

Если у Вас есть рак и Вы хотели бы получить некоторую информацию относительно того, как принимать B-17, а также какие пищевые продукты стоит включать в свой рацион, а какие не стоит, продолжайте чтение. Есть много полезных продуктов для улучшения вашего здоровья и предотвращения рака.

Примечание: Предоставьте вашему организму самому привыкать к изменениям, и начните с малой дозировки, постепенно ее увеличивая, иначе Вы можете заболеть.

Если Вы не имеете рака, но Вы хотите его предотвратить, ешьте от 7 до 10 семян абрикосов ежедневно, (начните с низкой дозировки, 1 или 2 семени в день и дойдите до 7 – 10. Старайтесь есть больше необработанных пищевых продуктов и не связывайтесь с обработанными пищевыми продуктами. Если необработанный продукт имеет на себе метку предупреждения, Вы уже знаете, что делать.

Помимо этого существует панкреатический фермент, который помогает разрушать белковую стенку вокруг раковой клетки. Вы можете получить этот фермент пищевым путем из простого необработанного ананаса, по возможности съедайте по одному ананасу в день вместе с семенами.

Начните принимать витамин С, сначала малые дозы (приблизительно от 500 до 1000 мг в сутки) и постепенно наращивайте дозу 10,000 мг в сутки). Это займет некоторое время, чтобы подготовить Ваш организм к новым условиям, так что не слишком старайтесь сразу же получать большие дозы. Слишком большие дозы могут вызвать головные боли, тошноту, понос, и т.д. Это не говорит о том, что продукт не работает. Напротив, это означает, что ваш организм слишком быстро детоксицируется, так что Вы должны снизить дозировку. Если Вы хотите избежать болезненных симптомов, Вы должны медленно детоксицировать Ваш организм. Независимо от того, насколько Вы уже разрушили Вашу иммунную систему химиотерапией или облучением, Вы должны хотеть восстановить ее насколько это возможно. Один из способов это сделать, связан с пробиотиками Ветом, они помогут довести вашу иммунную систему до того уровня, который необходим, чтобы бороться с раком и другими болезнями.

Пейте много питьевой воды. Чай с шиповника.

Выжатый сок благотворен для вашей печени. Можете купить побольше свеклы, смешать ее с другими овощами и выжать из них сок. Очень важно, чтобы Вы начинали медленно, поскольку поначалу Вы можете почувствовать себя плохо. Пейте его помалу (около 1/4 стакана) и медленно приходите к большим количествам. Свекольный сок будет очищать вашу печень от токсинов и сбрасывать их в организм, поскольку он один из лучших очистителей печени. Пейте воду (приблизительно от 8 до 10 стаканов воды в сутки), лучше всего – свежую, чистую, которая поможет Вам вывести токсины из организма.

Теперь по поводу пищевых продуктов. Вы не должны есть … сахар-рафинад, кофеин, муку высшего сорта, и старайтесь не есть мяса или есть его в очень небольших количествах. Вы можете есть мясо, но мясо забирает себе как раз те пищеварительные ферменты, которые помогают разрушать белковую стенку вокруг раковой клетки.

Сахар замените сладкой травкой Стевия.

Помимо этого, следует строго исключить из своей диеты табак и алкоголь.

Как это всегда бывает с любой новой вещью, вы должны начать с малого. Делайте то, что Вам подсказывает Ваш организм. Но, если Вы почувствуете себя больным, когда начнете делать то, что еще никогда не делали, не пугайтесь. Это не означает, что новая программа не работает. Просто нужно время, чтобы организм перестроился, а любая перестройка может быть болезненна. Возможно, Вы начали со слишком большой дозировки. Натуральные продукты сразу же начинают выводить токсины из вашего организма, и если Вы делаете это слишком быстро, это может заставить Вас почувствовать себя больным (эти симптомы похожи на грипп). Тогда уменьшите дозировку и снова начните ее медленно повышать.

Мнения многих ведущих докторов и ученых, которые с уверенностью заявляют Вам, что рак является прямым следствием недостаточности в организме витамина B-17. Вспомните, что цинга, рахит, пеллагра, явились результатом недостаточности витаминов B и C. Потребовались столетия (и миллионы жизней) прежде, чем короли и медицинская промышленность того времени восприняла простые истины и пришла к витаминным растворам в качестве лекарств. Сегодня, мы находимся в том же положении относительно рака. Рак — это эпидемия нашего века. И только мы сами можем предотвратить ее.

Витамин безвреден для тканей тела по простой причине: каждая молекула В17 состоит из одного соединения цианида, одного — бензолдехида и двух соединений глюкозы (сахара), плотно упакованных вместе. Чтобы цианид стал опасен, в первую очередь необходимо «вскрыть» молекулу и освободить его, на что способен только энзим под названием бета-глюкозидаза. Этот энзим присутствует во всем теле в минимальных количествах, но почти в 100 раз его больше в раковых опухолях.

Следовательно, цианид освобождается только в раковых участках тела с поразительными результатами, губительными для раковых клеток, потому что бензолдехид тоже освобождается в то же самое время. Это смертельный яд по своим свойствам, но в сочетании с цианидом он становится еще в 100 раз смертельнее. Производимый ими эффект на раковые клетки можно предоставить воображению.

Вы спросите — а есть ли опасность для остальных, здоровых клеток тела?

Другой энзим, роданез, всегда присутствующий в здоровых клетках в больших количествах, чем энзим-ключ бета-глюкосидаз, имеет способность преобразовывать и цианид, и бета-глюкосидаз в полезные продукты для тела. Всего вероятнее, что раковые клетки вообще не содержат роданеза и оставлены на произвол действия цианида и бензролдецида.

Но самое важное — это ваши молитвы. Делайте все с верой и молитвой, просите Бога об исцелении, о помощи, надейтесь на Его мудрость. Веруйте в Его способность исцелять.

http://ecology.md/page/etot-vitamin-ubivaet-rakovye-kletki
          Ampac Engineers Improved Anti-Fog Technology for Fresh Produce Pa   
1888PressRelease - Ampac has engineered an improved anti-fog technology for film used in fresh produce packaging. Ampac has been a long time supplier of surface printed anti-fog OPP film with controlled perforation for vegetables. Ampac, a division of ProAmpac, and the world's leader in creative flexible packaging solutions, has engineered an improved anti-fog technology for film used in fresh produce packaging. Ampac has been a long time supplier of surface printed anti-fog OPP film with controlled perforation for vegetables. From a market need, and through the efforts of a strong technical team, Ampac developed coated films with superior anti-fog properties that help prevent condensation for heat sealable films. Unlike other technologies, the new anti-fog coating technology has excellent seal and hot tack properties and does not impact the coefficient of friction (COF) of the films, while providing improved transparency for fresh produce. In addition, the features and performance of the anti-fog coating works in conjunction with tailored perforations in the film to control the respiration rate of different vegetables. This creates a unique combination that is attractive to grocers requiring improved properties for produce packaging. The anti-fog coating is exceptional for bag and lidding applications and is also FDA approved for microwave applications. According to Dr. Hesam Tabatabaei, ProAmpac's Director of Research, Innovation and Technology, "Our new anti-fog technology offers improved clarity with technical advances that improve line efficiencies on form fill and seal packaging machines. The improved clarity helps drive sales of fresh produce by highlighting the freshness of the product. We're excited to add this new anti-fog technology to ProAmpac's broad portfolio of innovative flexible packaging solutions." About Ampac Ampac is a division of ProAmpac and is part of the U.S. Flexibles Division. Ampac drives packaging transformation and performance by creating packages that are more innovative, progressive and dynamic than those used by competitive brands. Ampac's comprehensive approach to packaging is a balance of rigorous, technology-driven thinking and exceptional creativity. About ProAmpac ProAmpac is steadfast in their unwavering commitment to provide creative packaging solutions, industry-leading customer service and award-winning innovation to a diverse global marketplace. It is a diversified global packaging company with over 2,500 employees and 19 manufacturing centers in North America, Europe and Asia. For more information, visit our website at: http://www.proampac.com. Please forward inquiries to: ProAmpac 12025 Tricon Rd Cincinnati, OH 45246 Phone: (513) 671-1777 Fax: (513) 671-2920 Email: general ( @ ) ampaconline dot com
          Reading The Labels On Drugs And Food   
Do you read the labels on food before you buy it? How about on pill bottles, supplements, and other drugs? If some Rhode Island lawmakers have their way, you could be seeing "country of origin" labels on your pharmaceuticals. But would that change your mind about taking a drug, or make you ask your doctor for a different brand? Several state senators introduced a bill supporting "country of origin" labeling for drugs, citing fears that, because so many ingredients in our pharmaceuticals are manufactured overseas, our drugs may not be as safe as they would be were they made completely in the U.S. I'm not sure if those fears are well-founded, but I'm even more uncertain whether such labeling would give consumers information they can act on. What if there's only one brand available? Or you don't have time to research pharmaceutical supply chain safety in India or China? In other labeling news today, the FDA released its proposed changes to the food labels we've all grown so familiar with.
          Hiring for QA Manager   
Globex Digital Solutions - Hyderabad, Telangana - Andhra Pradesh - QA Manager for the Pharma Exposure should have exposure towards the Bulk Drugs. Exposure towards USFDA , Documentation & Audit ....
          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          Easy Ideas to Bear in mind With All The Dietary Supplements Apettite supressants 37.5 mg   
Apettite supressants 37.5 milligram  is a diet plan suppressor substance that is about approximately 30 years. Apettite supressants 37.5 mg  has been approved by the Fda standards along with the FDA doesn’t propose using the drug for longer than 12 several weeks. Apettite supressants 37.5 mg from http://phentermine.tv-gossip.com users need a medical doctor’s prescription for the […]
          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          Gottlieb plans to clear orphan drug backlog   

The new FDA Commissioner is trying to improve efficiency at the agency by plowing through the backlog of orphan drug designation requests. 


          Mágikus tojásfőző készlet / 6 + 1 részes szett - Jelenlegi ára: 1 290 Ft   

Vásárolj rizikó nélkül, egy megbízható eladótól! Ha nem felel meg a termék, visszahozhatod és visszaadjuk a pénzed.
Számla 1 év garancia
Mágikus tojásfőző - megkönnyíti az életed
Rakott krumpli, casino tojás tojássaláta, stefánia vagdalt?
Ezek mind finom ételek, de ezentúl még ízletesebbé varázsolhatod őket, és még sok, főtt tojással készült ételt, ráadásul a dolgok oroszlánrészét a tojáshéjpucolást is megspórolhatod!
Próbád ki a mágikus készletet és többé nem főzöl tojást héjában!
Használata egyszerű, csak törd fel a tojást, óvatosan öntsd át a formába, és mehet is a forró vízbe.
A tojásokat akár főzés előtt is kedved szerint fűszerezheted, létrehozva így egy új ízvilágot a casinotojás, hidegtálak rakottburgonya és más tojásos étkek készítésekor.
A tapadásmentes formákból egy mozdulattal kicsúsztathatod a főtt tojásokat, miután elkészültek, praktikus, egyszerű és könnyen tisztítható, akár mosogatógépben is mosható.
Tulajdonságok:
6 db-os tojásfőző készlet
Ajándék tojásszétválasztó kanál
Tapadásmentes kialakítás
Fda mentes, hőálló műanyag
Mosogatógépben tisztítható
Eredeti ár: 3 490 Ft
Akciós ár:
1 290 Ft
Keresd Bonzobonzijevics további akcióit termékeink között!

Mágikus tojásfőző készlet / 6 + 1 részes szett
Jelenlegi ára: 1 290 Ft
Az aukció vége: 2017-07-03 02:03
          Mágikus tésztaszűrő / edényekre, serpenyőkre - Jelenlegi ára: 1 490 Ft   

Vásárolj rizikó nélkül, egy megbízható eladótól! Ha nem felel meg a termék, visszahozhatod és visszaadjuk a pénzed.
Számla 1 év garancia
A tésztaszűrő
- amire szükséged van
A tésztafőzéshez nem kell különösebb szaktudás, a víz leszűrése azonban sokunknak jelent komplikációt : )
Őrült japán tudósok végre ezt is kitalálták, mi pedig elhoztuk neked, az egykezes tésztaszűrőt, ami valóban megkönnyíti majd a dolgod!
Ha elkészültél a főzéssel, egy mozdulattal rögzítheted bármilyen lábosra, fazékra, egy másik mozdulattal pedig egyszerűen, biztonságosan, öntheted is le a vizet, az edény tartalmáról.
Próbáld ki, és ezentúl nem kell a tésztadarabokat
a lefolyóból szedegetned!
Nézd meg hogy működik, klikk a videora!
A csomag tartalmazza:
- Bármilyen edényen használható
- Tészta, nokedli, galuska, zöldség, és bármilyen étel leszűréséhez alkalmas
- Anyaga: rugalmas, hőálló fda mentes műanyag
Eredeti ár: 3 990 Ft
Akciós ár:
1 490 Ft
Keresd Bonzobonzijevics további akcióit termékeink között!

Mágikus tésztaszűrő / edényekre, serpenyőkre
Jelenlegi ára: 1 490 Ft
Az aukció vége: 2017-07-03 02:03
          Arbor Pharmaceuticals, LLC Announces FDA Approval for Triptodur (triptorelin)   
Atlanta, GA and Lausanne, Switzerland – June 30, 2017 – Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, and Debiopharm International SA, part of Debiopharm Group™, a Swiss-based global biopharmaceutical company,...
          Texas’s Illegal Execution Drugs From India Have Expired. It Plans To Buy More.   

Pat Sullivan / AP

Three-thousand vials of a banned execution drug that Texas, Arizona, and Nebraska have been fighting for the right to use have now expired, and Texas has vowed to buy more.

The states paid $75,000 for the drug — sodium thiopental, a powerful anesthetic — two years ago despite a warning from federal officials that it would not be allowed into the country. The shipments were seized, and since that time, the states have been engaged in a legal standoff with the Food and Drug Administration, arguing that they should be permitted to use the drug for "law enforcement purpose only."

While the sides fought in court, however, the drugs expired and may no longer be effective. Texas has indicated that it plans to buy more.

Doing so is not a simple matter.

Outlawed in the United States, sodium thiopental is still used in other countries, but most reputable drugmakers have enacted stringent measures to keep their products from being used for executions. Which is what led the three states, last time around, to a supplier in India named Chris Harris.

Harris has billed himself as a manufacturer of the drug, but a BuzzFeed News investigation cast doubt on his claims. He has no scientific expertise. He has listed two Indian facilities with the FDA and the Drug Enforcement Administration — one is a small rented office space, and the other is an old apartment that he left still owing rent on.

Instead, Harris purchased the drugs from another manufacturer in India, slapped his label on the vials, and then resold them at a massive profit.

Harris has repeatedly declined to speak with BuzzFeed News. “I think you people don’t understand English,” Harris wrote in 2015. “I have said I won't waste my time replying to you as you will write whatever you want anyways. STOP SENDING ME MAILS.”

According to FDA documents obtained by BuzzFeed News through an open records request, his drugs expired in May 2017.

A spokesperson for the Texas Department of Criminal Justice said the lawsuit would continue.

In an affidavit last year that has not been made public until now, a state official whose name was redacted wrote that Texas "intends to continue importing thiopental sodium from the same foreign source, and with the same labeling, as the entry that FDA is currently detaining."

A TDCJ spokesperson said that the state had not yet purchased “any further drug from this supplier,” and would “reevaluate the situation at the conclusion of this case.”

In 2013, a federal appeals court found that the FDA had “a mandatory obligation” to block all illegal shipments of the drug. Since then, the FDA has maintained that it is “required to refuse entry” to the shipments.

Last time around, Texas initially planned to buy from another Indian supplier, but the deal fell through when the supplier was raided by the Indian government. Its employees were all arrested for allegedly selling opioids and party drugs illegally to Americans and Europeans.

Read the documents:


          Ice cream vs. gelato: An eat-this-or-that guide to summer's frozen desserts   
Before you order a double scoop or get out the ice cream maker, consult our this-vs.-that guide to the frozen treats of summer.Ice cream (and frozen custard) vs. gelatoTo be designated as ice cream, the FDA stipulates that the product contains at least 10 percent fat. If it has more than 1.4 percent egg yolks, then it can be called frozen custard, French [...]
          KOMPOSISI JASON WINTERS TEA   


JASON WINTERS TEA
RAMUAN HERBAL AJAIB 3 BENUA 


Merupakan kombinasi dari 3 macam ramuan herbal (Red Clover, Herbalene   dan  Chapparal ) dari 3 benua (eropa, amerika & asia) yang berfungsi memurnikan darah dan memberikan nutrisi sehingga kekebalan tubuh meningkat. ramuan ini ditemukan dan digunakan oleh sir Jason Winter ketika putus asa dalam usahanya menghadapi vonis kematian 90 hari dari penyakit kankerstadium akhir. 3 minggu setelah mengkonsumsi ramuan, di luar dugaan hasilnya sungguh menakjubkan: beliau berhasil mengalahkan dan membunuh kanker yang dideritanya! dan dalam waktu 9 mingguSir Jason sudah dapat bekerja secara normal (baca buku membunuh kanker/Killing Cancer-gramedia).

1. Red Clover berasal dari benua Eropa adalah tumbuhan padang rumput yg memiliki bunga berwarna merah muda, dan populer sebelum masehi digunakan untuk memurnikan darah. Tahun 1884 mulai digunakan sebagai terapi untuk penyakit kanker payudara dan pasiennya sembuh (New York Tribune) di dapati Sir Jason Winters dari referensi buku karangan Jethro Kloss yaitu “Gospel of Essence” tanaman ini bermanfaat untuk:
·         -Memurnikan darah,sebagai antibiotic dan antiseptik
·         -Meningkatkan kekebalan tubuh
·         -Membantu mengatasi masalah ginjal,liver dan saluran pernafasan atas
·         -Menanggulangi keadaan yg tidak menyenangkan akibat rendahnya kadar estrogen

2. Chaparralberasal dari benua Amerika, sejenis tanaman kaktus, satu-satunya tumbuhan yang mampu bertahan di tempat percobaan Nuklir Ground Zero dan daerah kelembaban tinggi (Death Valley). Tahun 1968-1969 diselidiki oleh FDA di Universitas Utah Medical Centre memiliki senyawa aktif SOD (Super Oxide Dismutase) yaitu Nordihydroguaiaretic Acid (NDGA) yg berfungsi sebagai antioksidant dan menjadikan Chaparral sebagai Tumbuhan Terkuat didunia (Sa Semana Medica 2:123,1955)Dr Smart & Hogle dari Universitas Utah Medical Centre menulis artikel kesehatan yang menampilkan Ernest Farr, usia 86 th yang sembuh dari penyakit Kanker dengan Chaparral.
Manfaat chaparral :
·         -Penghancur radikal bebas
·         -Menghambat pertumbuhan tumor dan kanker
·         -Berfungsi sebagai analgesic dan antiseptic
·         -Membantu menurunkan tekanan darah
·         -Memerangi efek dari radiasi  dan pembakaran akibat sinar matahari
·         -Baik untuk masalah-masalah kulit

3. Herbalenedari benua Asia adalah tumbuhan yang banyak terdapat di China, Tibet dan India sering dipakai dalam pengobatan Chinese medication (Fu Zheng) atau sering disebut tanaman Huang Qi & 2500 tahun yang lalu Sang Budha merekomendasikan untuk untuk penyembuhan Tumor, saat ini dikembangkan dalam pengobatan penyakit kanker dan stimulus mental. dalam pengobatan modern Fu Zheng diyakini dapat memulihkan kembali kekebalan tubuh yang hilang akibat dari terapi penyinaran (radiation) dan chemotherapy.

          Koogeek BP2 Arm Blood Pressure Monitor   
Stay up to date on your health with ease when you have the Koogeek BP2 Arm Blood Pressure Monitor. Both FDA and CE approved, this wearable gives you instant feedback with medical-grade accuracy and precision. The BP2 Monitor also gives you the opportunity to do multiple measurements in succession. Viewing the last five measurements, you can view an average to get an accurate reading. In addition, the BP2 Monitor works with families. In fact, you can have up to 16... Continue Reading
          Clinical Research Nurse - Mid-Atlantic Permanente Medical Group - Largo, MD   
Investigator CVs, financial disclosure forms, laboratory certifications, radiation safety exemptions, FDA 1572 forms, etc....
From Mid-Atlantic Permanente Medical Group - Wed, 22 Mar 2017 10:28:47 GMT - View all Largo, MD jobs
          Program Coordinator, FDA and Third Party Tobacco Retail Inspection Program - JBS International, Inc. - Maryland   
Experience in conducting data analysis, preferably using SQL server databases. A Bachelor's degree, in business administration, public administration, criminal...
From JBS International, Inc. - Fri, 02 Jun 2017 03:23:28 GMT - View all Maryland jobs
          (USA-WA-Spokane) Compliance Coordinator   
Job Descriptions: Here at etailz we are constantly seeking creative, motivated and tenacious employees who take ownership of their work, make meaningful contributions to something great and have a little fun while doing it. We aspire to maintain an environment where everyone looks forward to coming to the office each day, living by the cliché 'work hard, play hard'. RESPONSIBILITIES + Under the supervision of the Compliance Manager, this position will review new and current products & vendors for domestic and international marketplace compliance, legal compliance and possible importing/exporting regulations. + Qualified candidates should be communicative, personable, positive, driven, and be willing to appropriately accept pushback and provide pushback as needed. + This is primarily a research based position. Much time is spent reading legal, government, and technical documents and then providing analysis on how those regulations apply to our products and vendors. This person must provide accurate, clear and concise analysis and action steps to both internal teams and to our vendors. + The compliance team does oversee a variety of processes so additional job duties will be assigned as needed. Processes and needs can change often. We are looking for a team member who is adaptable, asks questions, and has an anything is possible attitude. + Other duties, as assigned Required Experience: QUALIFICATIONS + Bachelor’s degree preferred + Import/export or international retail experience preferred + EPA, FDA or regulatory experience preferred + Flexibility and willingness to take on new challenges + Superior verbal and written communication skills + Ability to provide concise, professional written documentation and recommendations + Excellent analytical, problem solving and quantitative skills + Detailed and inquisitive + Strong computer and software skills; Excel proficiency needed. + Works well independently and as part of a team + Applicants must be currently authorized to work in the United States for any employer. etailz, Inc., uses E-Verify to confirm employment eligibility of all newly hired employees. Keyword: Compliance Coordinator From: etailz, Inc.
          Four Devicemakers Cited for Inadequate Procedures   
The FDA cited Jensen Industries, Tyson Bioresearch, OsteoSymbionics and Innovative Sterilization Techniques over problems with their CAPA procedures, complaint handling and MDRs.
          Hospira’s Epoetin Biosimilar Delayed Following CRL Over GMP Violations   
Pfizer and its generic injectables arm, Hospira, received a complete response letter for their proposed biosimilar of epoetin alfa, also known as Epogen and Procrit, following manufacturing issues cited in a February FDA warning.
          FDA Relaxes 14-Year-Old Recommendations for Medical Gas GMP Compliance   
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing some recommendations on expiration dating and warehousing procedures.
          FDA Warns Vidco for Validation, MDR, Complaint-Handling   
A review of seven change notices for Vidco’s NetViewer MDP2040-0100 device found numerous discrepancies.
          FDA Authorizes Two In Vitro Devices for Zika Detection   
The agency also revoked the emergency use authorization it issued for Roche’s Zika test.
          FDA Relaxes 14-Year-Old Recommendations for Medical Gas GMP Compliance   
The previous version, issued in 2003, required that each container bear an expiration date, based on related storage conditions.
          FDA Orphan Products Office to Focus on Clearing Backlog   
The agency’s plan also includes implementing a new, streamlined template for reviewing orphan designations.
          Compounder Warned for Long List of GMP Violations   
A Texas-based compounder specializing in hormone therapies for men and women was warned by the FDA for extensive cGMP violations as well as producing drugs for which there was no valid prescription.
          FDA Orphan Products Office to Focus on Clearing Backlog   
To meet its goals of clearing a backlog of about 200 orphan designation requests before Sept. 21 — and committing to 90-day reviews thereafter — the FDA has formed a “SWAT team” of reviewers dedicated to the task, starting with the oldest applications first.
          FDA Clears Custom Ultrasonics to Resume Manufacturing Endoscope Reprocessor   
The filters underwent testing by independent laboratories with no change in design.
          GAO: Generics Getting Faster Approvals, but FDA Needs Plan to Use Extra GDUFA Funds   
The agency needs to have a better plan for the funds that are left over at the end of the fiscal year, the GAO said.
          FDA Publishes List of Generic-Ready NDAs, as Action Plan to Boost Competition Takes Shape   
The FDA will expedite the review of ANDAs until there are at least three generics approved for a given reference drug.
          FDA Taking Comments on BsUFA II Review Assessment Project   
To accommodate the increased interaction, the FDA said its review clock will begin after a 60-day administrative filing review period.
          EnvisionTEC Receives FDA Approval for E-Denture Material to 3D Print Removables   
...and 400 materials for the 3D printing of tooth restorations, EnvisionTEC now offers a complete digital denture workflow solution. (Photo: Business Wire) Combined with EnvisionTEC's FDA-approved E-Dent 100 and 400 materias for the direct printing of restorations that ...

          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          FDA реорганизует систему регистрации орфанных препаратов   
Администрация по контролю за продуктами и лекарствами США (FDA) заявила о реорганизации системы рассмотрения регистрационных заявок на препараты для лечения редких заболеваний. Целью является ликвидация пула из 200 орфанных лекарств, ожидающих решение контрольных органов.
          Common Lead Test Can Give False Results, FDA Warns   
Common blood tests for lead can give falsely-low results in certain cases, according to a new warning from the Food and Drug Administration. The tests, manufactured by Magellan Diagnostics , are commonly used in doctors' offices and clinics, and on its website the company calls itself "the most trusted name in lead testing." But the FDA now says that its tests can give inaccurate results when used to test blood drawn from a vein. The majority of lead tests are not conducted with that kind of blood sample, but rather blood from a heel or finger prick, says Dr. Jeffrey Shuren , director of the FDA's Center for Devices and Radiological Health. "We have no evidence that Magellan's tests, when used with blood obtained from a finger or heel stick, are impacted," says Shuren. "We believe most people will not be affected by this issue." For example, in 2016, the Centers for Disease Control and Prevention recommended that all children under the age 6 years in Flint, Mich., get re-tested as part
          Nustokite vartoti Ibuprofeną! Jis kasmet nužudo tūkstančius žmonių! Tai tikras nuodas!   
Nustokite vartoti Ibuprofeną! Jis kasmet nužudo tūkstančius žmonių! Tai tikras nuodas! Nuo 1999 iki 2003 m. buvo priskiriama apie 30 000 širdies sustojimo ir staigaus širdies mirties atvejų. Šis vaistas buvo susijęs su padidėjusiu širdies priepuolių ir insulto dažniu dar iki 2000 m., Tačiau Merck ir FDA šiuo klausimu tylėjo. Remiantis kitais „Lancet Medical Journal“ […]
          Tobacco Regulation vs. The Drug War   

If you want to know what Obama really thinks about tobacco, don't read his lips. Read his teeth. To relieve his addiction and protect his health, he's been chewing nicotine gum . The law he just signed authorizes the FDA to expedite approval of nicotine lozenges, gum, and patches. It encourages the agency to broaden the grounds for prescribing such products and to authorize their "extended use." It puts regulators smack in the middle of the nicotine business so they can turn it to better use. If only all our drug policies were this rational.

More here .


          The Week That Was    
by Savannah

The week that the tennis world found out that the woman who had been chosen as the face of her sport was doping for the last ten years is drawing to a close. Everyone, tennis fans and non fans is talking about the fall from grace of Maria Sharapova and what it means for the future of women's tennis.

Some of her fans (and those who are paid or not paid) to promote her on social media, are promoting a few things now.


  • She wasn't "officially doping" until January 1, 2016.
  • She is being persecuted because she is Russian.
  • The effects of meldonium are negligible, no more rousing than a double expresso.
  • A TUE may be granted.

Okay lets go one point at a time.

A man or woman hitting bottom and showing up at an AA, NarcAnon or Gamblers Anonymous meeting isn't a newly formed addict. They've engaged in the behavior that brought them to that meeting for many years and have finally reached the point where they can't stand themselves either. Acknowledging the fact that they're addicts doesn't mean that as of the day of their first meeting they became an addict does it?

Let's be clear. I'm not saying Ms Sharapova is a junkie. I'm making an analogy. However, what do you call someone who takes a medication they don't need (it bears repeating that her lawyer never said she had any of the medical conditions meldonium treats and that mentioning diabetes was a really silly thing to do) for ten years? Drugs like Vicodin, oxycontin and adderall all treat specific physical conditions, temporary or permanent. Those who take them when they're not needed are called what? Addicts. In sports they're called dopers.

Let's turn to sports then, specifically Lance Armstrong. He strongly denied, for years, that he was using PED's. He destroyed the careers of those who insisted that he did use them. And when the truth was revealed sports media was left with egg on its collective face. They'd reported the denials as truths and vilified those who "were out to get Armstrong" for years. And they were wrong.

It's because of the Armstrong case that I'm still surprised that Ms Sharapova and her lawyer took a page out of that book and came out of the gate charging citing medical use that has yet to be proven, telling a closed door meeting with chosen members of the press that Ms Sharapova had listed the drug on her declaration sheets she'd given to the ITF during the AO, and putting out cheerful press releases saying "the world is with Maria" and showing her romping on the beach with an unidentified male who was wearing a shirt that said "Sven" on the back. I should note in passing that none of the men who have coached Maria since her father stepped aside have said a word. Not one word that I'm aware of as I type this.

A Russian friend made me aware that the Russian press was taking the tack that Russian athletes were being persecuted by the West for geopolitical reasons. That argument has gone from one made only in Russian language forums to non Russian fan forums. I don't know what to say except that if even after the ban close to 60 of your athletes have tested positive for a drug that was on the watch list for all of 2015 and officially banned at the beginning of 2016 there is cause for concern.

I'm seeing this argument a lot now because fans are asking if tennis and sports media would've stepped so lightly if the person found to have doped for ten years was another player. "It's not racial" they say. Uh huh. I'll be charitable and say they're delusional. Or that their jobs depend on them pushing that meme.

If the effects of meldonium are so negligible why were so many athletes using it? Did it give them a buzz of some kind? Or did it, as has been alleged, increase endurance? Tennis fans can cite matches where Sharapova showed miraculous fight and endurance and many admire her for that if for nothing else. If it was so above board why did Sharapova, a 21 year resident of the US, have to buy the drug on her own after it was prescribed by a "family doctor" who has yet to be identified? If a doctor in the US prescribed and provided it to her he or she has probably hired a lawyer by now. If the doctor is based in Eastern Europe or Russia he or she is simply shrugging their shoulders and asking "what?".

Then there's the TUE (therapeutic use exemption) solution that was being bandied about. There are four criteria that have to be met in order for a TUE to be granted. You can't meet some of the criteria you have to meet them all.

1.1.2. Criteria for granting a TUE

The four criteria that must be fulfilled before a TUE is granted are set forth
in the International Standard for TUEs:

1. “The Athlete would experience a significant impairment to health if
the Prohibited Substance or Prohibited Method were to be withheld in
the course of treating an acute or chronic medical condition.” (Article
4.1 a. of the International Standard for TUEs.)

2. “The Therapeutic Use of the Prohibited Substance or Prohibited
Method would produce no additional enhancement of performance
other than that which might be anticipated by a return to a state of
normal health following the treatment of a legitimate medical
condition.
The Use of any Prohibited Substance or Prohibited Method to increase
“low-normal” levels of any endogenous hormone is not considered an
acceptable Therapeutic intervention.” (Article 4.1b of the International
Standard for TUEs.)
Enhancement of performance should be taken to mean the return by the
Athlete to his/her level of performance prior to the onset of the medical
condition requiring treatment. This means that there may be some
enhancement of individual performance as a result of the efficacy of the
treatment. Nevertheless, such enhancement must not exceed the level of
performance of the Athlete prior to the onset of his/her medical condition.

3. “There is no reasonable Therapeutic alternative to the Use of the
otherwise Prohibited Substance or Prohibited Method.” (Article 4.1
c of the International Standard for TUEs.)
Two points should be noted in relation to reasonable Therapeutic
alternatives:
 Only valid and referenced medications are considered as
alternatives.
 The definition of what is valid and referenced may vary from one
country to another. These differences should be taken into
account. For example, a medication may be registered in one
country and not in another, or approval may be pending, etc.

4. “The necessity for the Use of the otherwise Prohibited Substance or
Prohibited Method cannot be a consequence, wholly or in part, of
prior non-Therapeutic Use of any Substance from the Prohibited
List.” (Article 4.1 d. of the International Standard for TUEs.)


Once these guidelines were posted on Twitter the TUE option kind of went away. Some fanatics tried to post only some of the requirements but other fans posted all four.

So what conclusions are to be drawn?

Ms Sharapova's lawyer John Haggerty did an interview with Simon Cambers of The Guardian newspaper where he appears to walk back several of the talking points that had been put to the public. The following is from that interview linked above.

Q) Did she put meldonium on those forms?
A) Maria never took meldonium, she took mildronate. I’m in the process … I’ve yet to review those forms so I can’t answer that question. I simply do not know.
Q) There has been talk that Maria could ask for a retrospective TUE (therapeutic use exemption). Has Maria asked for one, can she ask for one?
A) We’re evaluating all of Maria’s options and since the TUE process is confidential I’m not in a position to be able to comment either way in what she has or has not done in that regard.
Q) Is there a time limit on doing this?
A) I’m not aware of any timeframe with regard to submission of such a thing.
Q) Meldonium is not licensed in the US so there are questions about where Maria got it from, as individuals are banned from importing it into the US. Has the FDA (Food and Drug Administration) been in touch with you?
A) The FDA has not been in touch with me. It is an over-the-counter medicine that is readily available in a number of countries. Maria legally purchased it and obtained it and has been taking it per her doctor’s recommendations.
Q) So would she have been buying it outside of the US?
A) Given that goes into the medical records and out of respect for the ITF (International Tennis Federation) process, I’m not going to be able to respond to that.

Poor Lindsay Davenport. She's become collateral damage in this situation. She reported to Tennis Channel viewers what Haggerty said in that closed door invitation only meeting - that the forms submitted in Melbourne showed meldonium as one of the drugs she was taking. Sharapova's fans are still trying to say "but Lindsay said" but that doesn't wash since Sharapova's lawyer waffled when asked about it directly.

Saying that it was Mildronate and not meldonium is ridiculous since they're one and the same. Mildronate is the name it's sold to the public by. Meldonium is the active ingredient, the generic name much is the way "Advil" is the retail name for ibuprofen. I give credit to Cambers for asking where she got it from. His question provoked another non answer from Haggerty.

So back to those conclusions.

Ms Sharapova's people have been silent for a couple of days now. Again I'm writing this post so I haven't been able to check and see if anything new has been said by anyone associated with the case.

Tennis media has also gone pretty quiet. There really isn't much to say now is there? Chris Evert, with whom I've had many disagreements, did an interview with ESPN that is must see video. I think she sums things up better than anyone else has so far. As we all know she can't be called an apologist for any player other than Sharapova. In that she went along with the entire ESPN on air staff. Here is the link to her interview . It was after this that a lot of the reporting changed from rah-rah to taking a sober look at the facts.

While watching tennis yesterday in the middle of a match Mary Carillo and Lindsay Davenport started talking about if Maria Sharapova is required to give back the money she won at Melbourne it should be evenly distributed among the players she beat.

I will repeat what I said in my first post about this. All any of us can do is wait.

© Savannahs World 2016 All rights reserved.



          Ketamine Clinics Show Promise For Treatment-Resistant Depression   

ketamine infusions ketamine for depression

From cat tranquilizer to party drug to novel antidepressant, ketamine has come a long way in the past 55 years. Originally developed as an affordable and effective anesthetic, it has recently become the latest line of defense for treatment-resistant depression, anxiety, PTSD, OCD and even nerve-related pain disorders like fibromyalgia or neuropathy. In most cases, the treatment is offered in the form of infusion supervised by clinical coordinators and/or medical doctors. Currently, the treatment is considered an off-label use, meaning that it hasn’t been specifically approved by the FDA for these conditions but due to overall safety and effectiveness after multiple research studies and anecdotal evidence from ketamine clinic patients, the practice is slowly becoming more mainstream.

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          (Seoul) Logistics Coordinator - Korea   
**Job Description:** **Scope of Position:** This position is primarily responsible for supply chain and demand planning activities for B-F Korea including inventory procurement, compliance & regulation work related to the importation and clearance of goods through the appropriate government agencies. The inventory procurement work includes developing inventory forecasts in cooperation with the commercial team, inventory management and customs clearance etc. Compliance & regulation work is related to the requirements of KFDA and customs office. The position is also responsible for customer service work and credit control. Customer service work is overall sales order management including taking orders, order input into SAP and billing to customers (wholesalers). **Responsibilities:** + Handle overall inventory management including inventory procurement (importation of finished goods). + Compliance with KFDA, FTA and customs office regulation requirements. + Prepare weekly/monthly sales report. + Handle overall sales order management including taking orders, order input into SAP and billing to customers (wholesalers). + Manage sales staff’s requests and issues, and provide necessaryinformation to resolve the issues. + Monitor AR status and issue monthly credit report. + Management of extended producer responsibility (glass bottle recycling etc.). + Conduct various analysis (Volume analysis by channel, discount analysis etc.). + Develop and maintain positive and constructive relationships with all relevant internal and external stakeholders. **Qualifications & Requirements** **Must Requirements:** + Bachelor’s degree + 5-6 years of experience as logistics specialist. + Excellent communication skills. + SAP experience in MM/SD module. + Excellent Excelskills. + Analytical skill. + Fluent in English (Verbal and written). **Preferred Requirements:** + Experience in the FMCG, food or liquor industry. + Customer service experience + Credit control experience \#LI CH1 \#BFBronze **About Brown-Forman:** About Brown-Forman: COMPANY: For more than 145 years, Brown-Forman Corporation has enriched the experience of life by responsibly building fine quality beverage alcohol brands, including Jack Daniel’s Tennessee Whiskey, Jack Daniel’s & Cola, Jack Daniel’s Tennessee Honey, Jack Daniel’s Tennessee Fire, Gentleman Jack, Jack Daniel’s Single Barrel, Finlandia, Korbel, el Jimador, Woodford Reserve, Old Forester, Canadian Mist, Herradura, New Mix, Sonoma-Cutrer, Early Times, Chambord, BenRiach and GlenDronach. Brown-Forman’s brands are supported by nearly 4,600 employees and sold in approximately 160 countries worldwide For more information about the company, please visit http://www.brown-forman.com. We're on Twitter: https://twitter.com/BrownFormanJobs See us on LinkedIn: https://www.linkedin.com/company/brown-forman Brown-Forman Corporation is committed to equality of opportunity in all aspects of employment. It is the policy of Brown-Forman Corporation to provide full and equal employment opportunities to all employees and potential employees without regard to race, color, religion, national or ethnic origin, veteran status, age, gender, gender identity or expression, sexual orientation, genetic information, physical or mental disability or any other legally protected status. **Business Area:** ANZSEA **City:** Seoul **State:** Int'l **Country:** Korea, South **Req Type:** Exempt **AutoReqId:** 3815BR
          (USA-WA-Spokane) Compliance Coordinator   
Job Descriptions: Here at etailz we are constantly seeking creative, motivated and tenacious employees who take ownership of their work, make meaningful contributions to something great and have a little fun while doing it. We aspire to maintain an environment where everyone looks forward to coming to the office each day, living by the cliché 'work hard, play hard'. RESPONSIBILITIES + Under the supervision of the Compliance Manager, this position will review new and current products & vendors for domestic and international marketplace compliance, legal compliance and possible importing/exporting regulations. + Qualified candidates should be communicative, personable, positive, driven, and be willing to appropriately accept pushback and provide pushback as needed. + This is primarily a research based position. Much time is spent reading legal, government, and technical documents and then providing analysis on how those regulations apply to our products and vendors. This person must provide accurate, clear and concise analysis and action steps to both internal teams and to our vendors. + The compliance team does oversee a variety of processes so additional job duties will be assigned as needed. Processes and needs can change often. We are looking for a team member who is adaptable, asks questions, and has an anything is possible attitude. + Other duties, as assigned Required Experience: QUALIFICATIONS + Bachelor’s degree preferred + Import/export or international retail experience preferred + EPA, FDA or regulatory experience preferred + Flexibility and willingness to take on new challenges + Superior verbal and written communication skills + Ability to provide concise, professional written documentation and recommendations + Excellent analytical, problem solving and quantitative skills + Detailed and inquisitive + Strong computer and software skills; Excel proficiency needed. + Works well independently and as part of a team + Applicants must be currently authorized to work in the United States for any employer. etailz, Inc., uses E-Verify to confirm employment eligibility of all newly hired employees. Keyword: Compliance Coordinator From: etailz, Inc.
          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          FDA application accepted for HIV drug with new mechanism of action   
MONTREAL, Canada – Theratechnologies Inc. (Theratechnologies) (TSX: TH) announced Friday that it has been notified by its partner, TaiMed Biologics, Inc., that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1). If approved, ibalizumab will […]
          Regulatory Affairs Associate III, Pre Approval - Teva Pharmaceuticals - Parsippany, NJ   
Interacts with FDA and all Teva sites via written and phone communications. Interpersonal Demonstrates ability to establish sound professional relationships...
From Teva Pharmaceuticals - Fri, 31 Mar 2017 16:03:18 GMT - View all Parsippany, NJ jobs
          Clinical Research Nurse - Mid-Atlantic Permanente Medical Group - Largo, MD   
Investigator CVs, financial disclosure forms, laboratory certifications, radiation safety exemptions, FDA 1572 forms, etc....
From Mid-Atlantic Permanente Medical Group - Wed, 22 Mar 2017 10:28:47 GMT - View all Largo, MD jobs
          Program Coordinator, FDA and Third Party Tobacco Retail Inspection Program - JBS International, Inc. - Maryland   
Experience in conducting data analysis, preferably using SQL server databases. A Bachelor's degree, in business administration, public administration, criminal...
From JBS International, Inc. - Fri, 02 Jun 2017 03:23:28 GMT - View all Maryland jobs
          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          Acquista Viagra Sildenafil Citrate / Fda Approvato Pharmacy / Consegna in tutto il mondo (3-7 giorni)   
Acquista Viagra Sildenafil Citrate Generico Viagra Migliore farmacia Per ordinare generico 25 mg Viagra senza ricetta. Viagra Generico è usato nel trattamento negli uomini della disfunzione erettile (DE), o impotenza. Valutazione 4.3 sulla base di 230 voti. Prezzo da €0.31 Per pillola Use this link to Order Generic Viagra (Sildenafil Citrate) NOW! conveniente Viagra Sildenafil […]
          Shisha is harmful, avoid it - FDA warns   
The Head of the Tobacco and Substance Abuse Unit of the Food and Drugs Authority, Mrs Olivia Boateng, has stressed that the belief among many young people that ‘shisha’ is not as harmful as cigarette is not true.
          Your pet food may be contaminated   

SAN FRANCISCO (KPIX 5) -- There are plenty of regulations intended to keep human food safe, but there are new concerns about pet foods. There have been thousands of pets with illnesses or deaths linked to pet foods in recent years. And in many cases, the pet owners don't know what in the foods made their pets sick. The FDA has received over 9,000 pet food complaints since 2010 ranging from diarrhea to death. Now, lab tests commissioned by the Clean Label Project are shedding light on what they say are shocking levels of contaminants lurking in pet foods. Jackie Bowen said, “Seeing lead levels that were 55 times those observed in the Flint, Michigan drinking water” was among the most surprising part of the tests. Bowen says they worked with Ellipse Analytics to test 900 of the bestselling pet foods and treats for over 130 contaminates and toxins. Jackie Bowen said, “We're talking about lead, arsenic, mercury, cadmium.” Instead of nutrition, she says they focused solely on contaminates which the lab says it found in products from nearly every brand tested. Though levels varied dramatically from product to product within each brand.


          Senior Software Development Manager - Illumina - Singapore   
Experience in biotech is a plus, as is experience with developing SW to FDA clinical standards. Senior Manager Software....
From Illumina - Fri, 30 Jun 2017 12:44:08 GMT - View all Singapore jobs
          BREAKING: FDA Approves New Drug For Liberal Snowflakes…   

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          Comment on Podcast 196 – Having a Vomit SALAD with Dr. Jim DuCanto – Airway Management Techniques during Massive Regurgitation, Emesis, or Bleeding by Jim DuCanto   
Hi Zac, sorry for the delay in answering your question. I’ve made mock-ups of just such a system (looks like a double-barrel, sided-by-side shotgun), but have concluded that it works great in simulation but would be bulky in actual practice at the present time. Current FDA labeling on rigid suction catheters are another concern (in other words, a company will not make something that the FDA will not let them sell), however, and in a few short years, we may have an opportunity to make such a “creature catheter.” Thanks for your question and excellent suggestion!
          Osteoarthritis Prevention and Wellness Protection Strategies   
Posted October 18, 2016

By Jeffrey B. Driban, PhD, ATC, CSCS

How many Athletic Trainers (ATs) can remember a patient who tore an anterior cruciate ligament (ACL), returned to visit a few years later and described chronic knee pain and limitations with their favorite activities?

The Bone and Joint Health National Awareness Week is a great time to focus on injury/illness prevention and wellness protection strategies that can help preserve long-term health. This is particularly relevant if we consider that 37 percent of ATs think osteoarthritis – a chronic painful and disabling condition – is not a major health concern.1 Furthermore, only approximately 70 percent of ATs discuss with a patient their risk for osteoarthritis and strategies to mitigate this risk.

In contrast, over 80 percent of adults after an ACL injury believe that knee osteoarthritis would be a major health concern and only 27 percent recalled having a conversation with their health professional about osteoarthritis risks associated with their knee injury.2 While many patients focus on short- and medium-term goals like return to play, it is vital that ATs provide patients with information about what they can expect after an injury. Let us consider some key questions.

What is osteoarthritis?

Osteoarthritis – the most common form of arthritis – is a progressive disease that affects all the tissues in a synovial joint. Osteoarthritis reflects a failed attempt to repair joint damage that is caused by stress on a joint. Osteoarthritis can be thought of as a disease, which is defined by the structural changes in a joint like bone spur formation or cartilage damage. It can also be thought of as an illness, which is defined by a patient’s reported experience like joint pain or other symptoms.3

Is osteoarthritis a major health concern?

Over 30.8 million million adults in the United States have osteoarthritis.4 Osteoarthritis is among the top 15 causes of disability.5 Osteoarthritis causes over $10 billion in annual absenteeism6 and more than $185 billion/year in healthcare expenditures.7 Unfortunately, a patient is at risk for early-onset osteoarthritis after a joint injury. This is troubling because adults 20 to 55 years of age with hip or knee osteoarthritis are 4 times more likely to be psychologically distressed compared with their peers. Furthermore, 67 percent of these patients report osteoarthritis-related work disability and approximately 40 percent report reduction in quality of life.8

Which physically active individuals are at risk for osteoarthritis?

Most adults who take part in physical activity and sports are safe and possibly even protected against osteoarthritis.9 However, men in soccer and certain elite-level sports may be at greater risk for hip or knee osteoarthritis.10,11 It remains unknown if these specific sports cause osteoarthritis or if other factors are the culprits (for example, the amount of training the athlete performs, the types of injuries that occur or how we manage an injury). Among our patients, one of the strongest risk factors for osteoarthritis is joint trauma. Individuals with a history of knee injury are 3 to 6 times more likely to develop osteoarthritis.12 Within the first decade after a knee injury, 1 in 3 patients develop osteoarthritis.13,14 Hence, a 20-year-old athlete who tears her ACL is at elevated risk for osteoarthritis by 30 years of age, which could lead to knee symptoms and then have a major impact on her work and quality of life for decades.

What can we do to prevent osteoarthritis?    

An injury prevention program can reduce the risk of injury by 35 to 68 percent.15,16 Furthermore, lower limb injury prevention programs can improve performance, keep athletes on the field and be easily implemented in a team warm-up. Recently, the Osteoarthritis Action Alliance, of which the NATA is a member organization, released a Consensus Opinion on the Best Practice Features of Lower Limb Injury Prevention Programs (Executive Summary). The task force identified 6 core components that should be included as part of a training program for prevention of major joint injury among youth athletes:

1. lower extremity and core muscle strength training

2. plyometric - jump training

3. balance training (as part of a program)

4. continual feedback on proper technique

5. sufficient dosing and compliance

6. minimal to no extra equipment

Unfortunately, we are unable to prevent every injury. Hence, we need to educate our patients about their risk for osteoarthritis and secondary prevention strategies that could help delay or prevent the onset of osteoarthritis. Secondary prevention strategies include regular exercise and weight management. These concepts will be expanded upon in the Athletic Trainers’ Osteoarthritis Consortium’s review and recommendations on the role of ATs in preventing and managing post-traumatic osteoarthritis in physically active individuals. The article will published by the Journal of Athletic Training in Spring 2017.

It is important to recognize that ATs are in a key position to help prevent this chronic disabling disorder and have a lasting effect on a patient’s long-term health and wellness. So next time you treat an injury, think long-term and talk with your patient about their future risk of osteoarthritis and how they can help reduce their chances of getting it.

References

1.  Pietrosimone BG, Blackburn JT, Golightly YM, et al. Certified Athletic Trainers'' Knowledge and Perceptions of Posttraumatic Osteoarthritis After Knee Injury. Journal of athletic training. 2016.

2.  Bennell KL, van Ginckel A, Kean CO, et al. Patient Knowledge and Beliefs About Knee Osteoarthritis After Anterior Cruciate Ligament Injury and Reconstruction. Arthritis Care Res (Hoboken). 2016; 68(8):1180-1185.

3.  Lane NE, Brandt K, Hawker G, et al. OARSI-FDA initiative: defining the disease state of osteoarthritis. Osteoarthritis Cartilage. 2011; 19(5):478-482.

4. Cisternas MG, Murphy L, Sacks JJ, et al. Alternative Methods for Defining Osteoarthritis and the Impact on Estimating Prevalence in a US Population-Based Survey. Arthritis Care Res (Hoboken). 2016; 68(5):574-580.

5. Vos T, Flaxman AD, Naghavi M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2013; 380(9859):2163-2196.

6.  Kotlarz H, Gunnarsson CL, Fang H, Rizzo JA. Osteoarthritis and absenteeism costs: evidence from US National Survey Data. J Occup Environ Med. 2010; 52(3):263-268.

7.  Kotlarz H, Gunnarsson CL, Fang H, Rizzo JA. Insurer and out-of-pocket costs of osteoarthritis in the US: evidence from national survey data. Arthritis Rheum. 2009; 60(12):3546-3553.

8. Ackerman IN, Bucknill A, Page RS, et al. The substantial personal burden experienced by younger people with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2015; 23(8):1276-1284.

9. Urquhart DM, Tobing JF, Hanna FS, et al. What is the effect of physical activity on the knee joint? A systematic review. Med Sci Sports Exerc. 2011; 43(3):432-442.

10. Driban JB, Hootman JM, Sitler MR, Harris K, Cattano NM. Participation in certain sports is associated with knee osteoarthritis: a systematic review. Journal of athletic training. In Press.

11. Michaelsson K, Byberg L, Ahlbom A, Melhus H, Farahmand BY. Risk of severe knee and hip osteoarthritis in relation to level of physical exercise: a prospective cohort study of long-distance skiers in Sweden. PLoS One. 2011; 6(3):e18339.

12. Muthuri SG, McWilliams DF, Doherty M, Zhang W. History of knee injuries and knee osteoarthritis: a meta-analysis of observational studies. Osteoarthritis Cartilage. 2011; 19(11):1286-1293.

13. Harris K, Driban JB, Sitler MR, Cattano NM, Balasubramanian E. Tibiofemoral Osteoarthritis After Surgical or Nonsurgical Treatment of Anterior Cruciate Ligament Rupture: A Systematic Review. Journal of athletic training. 2015; In Press.

14. Luc B, Gribble PA, Pietrosimone BG. Osteoarthritis Prevalence Following Anterior Cruciate Ligament Reconstruction: A Systematic Review and Numbers-Needed-to-Treat Analysis. Journal of athletic training. 2014; 49(6):806-819.

15. Sugimoto D, Myer GD, Barber Foss KD, Hewett TE. Specific exercise effects of preventive neuromuscular training intervention on anterior cruciate ligament injury risk reduction in young females: meta-analysis and subgroup analysis. Br J Sports Med. 2014.

16. Emery CA, Roy TO, Whittaker JL, Nettel-Aguirre A, van Mechelen W. Neuromuscular training injury prevention strategies in youth sport: a systematic review and meta-analysis. Br J Sports Med. 2015; 49(13):865-870.

About the Author

 Jeffrey B. Driban, PhD, ATC, CSCS is an Assistant Professor in the Division of Rheumatology at Tufts University School of Medicine and Tufts Medical Center. The goal of his research is to explore novel biochemical and imaging markers to gain a better understanding of osteoarthritis and potential disease phenotypes. Dr. Driban received his Bachelors of Science in Athletic Training from the University of Delaware. He received a Masters of Education and Doctor of Philosophy in Kinesiology with an Emphasis in Athletic Training from Temple University. He completed a post-doctoral research fellowship in the Division of Rheumatology at Tufts Medical Center where he continued his osteoarthritis focus. Dr. Driban also aims to raise awareness about osteoarthritis and promote primary and secondary prevention strategies for physically active individuals as the Chair of the Athletic Trainers’ Osteoarthritis Consortium and by serving as a National Athletic Trainers’ Association’s representative in the Osteoarthritis Action Alliance and Chair of the Alliance’s Osteoarthritis Prevention Work Group. Dr. Driban is also co-founder of Sports Medicine Research Company, which provides a blog and podcast focused bridging the gap between research and clinical practice related to sports medicine.

 


          What are the Health Risks of E-Cigarettes? Are E-Cigarettes a Safer Alternatives to Tobacco Cigarettes?   
Posted May 12, 2016

Nicole T. Wasylyk, MSEd, LAT, ATC

By Nicole T. Wasylyk, MSEd, LAT, ATC

Electronic cigarettes (e-cigarettes) are a type of electronic nicotine delivery system (ENDS), which are battery powered products delivering nicotine in the form of an aerosol or vapor.  ENDS, which include e-cigarettes, e-hookahs, hookah pens and vape pens, contain a liquid solution commonly composed of propylene glycol, glycerin, nicotine and flavoring agents. These agents are then heated to create an inhalable aerosol.

E-cigarettes were first invented in Beijing, China by Pharmacist Hon Lik in 2003. Hon created the e-cigarette as a means to reduce tobacco smoking dependency; however, its efficacy in reducing dependency is now highly debated. Many of the ENDS products are marketed as healthier alternatives to tobacco or as a means of tobacco cessation, yet there is no current evidence to suggest ENDS are efficacious smoking cessation aids.1

E-cigarette use is rapidly increasing. The CDC reported in 2014 that approximately 12.6% of adults have tried an e-cigarette at one time in their lifetime with 3.7% being current everyday users.3  In teenage populations ENDS use more than doubled from 4.7% in 2011 to 10% in 2012.4  Sales have also risen over the past years with an estimated $3 billion spent globally in 2013.5  Although there is little evidence on the healthcare associated cost resulting from ENDS use, we do know the US healthcare costs for smoking-related illnesses are more than $300 billion annually.6

ENDS products are currently unregulated whereas tobacco cigarettes are regulated by the FDA. ENDS and e-cigarettes may contain any number of chemicals, and companies are not currently obligated to disclose this information. Lab tests conducted by the FDA in 2009 found cancer-causing chemicals in some e-cigarettes to include diethylene glycol, a chemical commonly found in antifreeze that is toxic to humans. They also found nicotine levels vary greatly even in products of the same label.7

So why do some think e-cigarettes are a safer alternative to tobacco smoking?

Smoking has known cancer causing effects and profound effects on tissue microenvironment. It affects both the inflammatory response and reparative cell function, which can lead to delayed healing. Tobacco has been shown to delaying the inflammatory response and impairing bactericidal activity. This delay reduces the body’s ability to control wound contamination, thus leading to a higher risk of infection.8 Tobacco also causes a vasoconstrictive response, believed to be an effect of nicotine. ENDS are thought to be safer since they lack tobacco. They do however contain nicotine along with a number of unknown chemical compounds. Further research is needed on ENDS regarding y their safety and their effects for both users and second-hand exposure.

As ENDS and e-cigarettes become more prevalent in our society, it is important to understand the associated risks with these unregulated items. It’s also important to consider counselling patients and student-athletes on risks of tobacco and nicotine use, especially in regard to their detrimental effects on healing and recovery from injury or surgery. Most importantly, ENDS should not be considered a safer alternative to tobacco or used as a means of tobacco cessation. Effective ways to quit smoking and ENDS use can include avoidance, individual or group counseling; behavioral therapy; over-the-counter or prescription medication or a combination of treatments. The US Public Health service has found combination therapy (medication and counselling) to be most effective in smoking cessation.9

For more information and resources on smoking cessation please visit www.smokefree.gov or call 1-800-QUIT-NOW (1-800-784-8669)

Resources

1. http://escholarship.org/uc/item/13p2b72n#page-2

2. http://www.stopcancerfund.org/uncategorized/are-e-cigarettes-safer-than-regular-cigarettes/

3,4. http://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/index.htm

5. http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6_10-en.pdf

6. Xu X, Bishop EE, Kennedy SM, Simpson SA, Pechacek TF. Annual Healthcare Spending Attributable to Cigarette Smoking: An Update[PDF–157 KB]. American Journal of Preventive Medicine 2014;48(3):326–33 [accessed 2015 Aug 17].

7. http://www.fda.gov/downloads/drugs/scienceresearch/ucm173250.pdf

8. Sorensen LT Wound healing and infection in surgery: the pathophysiological impact of smoking, smoking cessation, and nicotine replacement therapy: a systematic review. Ann Surg. 2012 Jun; 255(6): 1069-79

9. http://www.lung.org/stop-smoking/smoking-facts/e-cigarettes-and-lung-health.html

About the Author

Nicole Wasylyk works as an Athletic Trainer in a physician practice at Dartmouth-Hitchcock Medical Center (DHMC) in Lebanon, New Hampshire. Prior to DHMC she resided in Madison, Wisconsin and was an Athletic Trainer in a physician practice at Meriter-Unity Point Health. Wasylyk obtained her Bachelor of Science in Athletic Training from Boston University and Masters of Science in Education from Old Dominion University. She has completed a residency program for healthcare providers who extend the services of a physician at UW Health. Wasylyk also obtained her orthopedic technician certification. Her professional interests include injury surveillance and prevention, standardization of best practices and patient reported outcomes collection. 

 

 

 

          Sodium’s Role in the Hydration Practices of an Active and Healthy Population   
Posted March 31, 2016

Mike McKenney
MS, ATC

By Mike McKenney, MS, ATC

In a previous blog post, I briefly mentioned sodium ingestion plays a significant role in the application of hydration strategies. This is a topic often met with some confusion as there are many different recommendations available to healthcare providers. These recommendations can have a direct effect on the fluid balance of an athlete, such as those from the CDC1 and the FDA.2 With that said, this post is not intended to refute the CDC and FDA recommendations, or downplay potential health risks of excessive sodium ingestion, but rather provide a more refined context on the role sodium plays in the hydration practices of an active and healthy population.

Sodium should not be actively avoided by athletes. It is the primary electrolyte that helps drive thirst and maintain appropriate fluid balance in the extracellular fluid space.3 Repetitive bouts of exercise with insufficient sodium replacement can lead to decreases in plasma volume due to an athlete''s inability to retain water. This further reduces an athlete''s performance as well as the ability to tolerate exercise in hot environments.4 Exercise-associated muscle cramping (EAMC) is a condition commonly assumed to be the result of decreased sodium levels. However, recent investigations indicate there is no reliable, scientific link between EAMC and sodium loss.5 But if athletes should be ingesting sodium, how much is appropriate to ingest?

According to the CDC1,consuming excessive amounts of sodium will have negative effects on the human body to include increased risk of heart disease and high blood pressure. However, similar to general hydration recommendations, sodium recommendations are made to be broadly applied to the general population. The FDA2 agrees with the aforementioned statement, but adds a caveat to their recommendation (added emphasis is mine): "Sodium is an essential nutrient and is needed by the body in relatively small amounts (provided that substantial sweating does not occur)." As Athletic Trainers (ATs), we often find ourselves in settings where substantial sweating is not only a normal occurrence for our patients, but a daily one, which places them in a population who have different needs.

It should not be assumed that a typical diet will be sufficient to replace sodium in athletes. Sweat sodium concentrations and sweat rates can vary widely6, resulting in the need for individual replacement plans. In situations where fluid loss is great, sodium losses can far exceed standard nutritional recommendations. Currently, it is recommended adults 14 and older should consume about 2.3g of sodium per day.7 However, it has been demonstrated athletes can easily exceed this recommendation in a single training session or game:

- Ice-hockey players can lose 5.7g in a single game8

- Soccer players can lose 2.4g in a single training session9

- Football players can lose up to 17.5g following a two-a-day practice6

Likewise, due to large variations in sweat rate and sweat sodium concentrations, some athletes are perfectly fine with their diet alone. Knowing how much an athlete needs is necessary in order to make an appropriate recommendation, and this can be accomplished with minimally invasive sweat testing services offered by a number of companies. Additionally, replacement can be achieved with the sodium consumed as part of a meal, such as chicken noodle soup,10 or with a number of commercially available products. However, care needs to be taken to understand an athlete’s medical history prior to making any sodium supplementation recommendations in order to account for medical conditions where this practice is potentially contraindicated.

Resources

1. http://www.cdc.gov/salt/

2. http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm315393.htm (Know Your Numbers)

3. Shirreffs S, Maughan R. Volume repletion after exercise-induced volume depletion in humans: replacement of water and sodium losses. Am J Physiol. 1998;274(5 pt2):F868-875.

4. Shirreffs SM, Sawka MN. Fluid and electrolyte needs for training, competition, and recovery. J Sports Sci. 2011;29(S1):S39-S46.

5. Murray D, Miller KC, Edwards JE. Does a reduction in serum sodium concentration or serum potassium concentration increase the prevalence of exercise-associated muscle cramps? J Sport Rehabil. 2015 [Epub ahead of print]. 

6. Fowkes-Godek S, Peduzzi C, Burkholder R, Condon S, Dorshimer G, Bartolozzi AR. Sweat rates, sweat sodium concentrations, and sodium losses in 3 groups of professional football players. J Athl Train. 2010;45(4):364-371.

7. http://health.gov/dietaryguidelines/2015/guidelines/

8. Godek, S.F., Godek, J.J., McCrossin, J., and Bartolozzi, A.R. 2006. Sweat and sodium losses in professional ice hockey players during a pre-season practice and a game. Med Sci Sports Exerc. 38: S218–S219.

9. Maughan R, Merson S, Broad N, Shirreffs S. Fluid and electrolyte intake and loss in elite soccer players during training. Int J Sport Nutr Exerc Metab. 2004;14(3):333-346

10. Ray ML, Bryan MW, Ruden TM, Baier SM, Sharp RL, King DS. Effect of sodium in a rehydration beverage when consumed as a fluid or meal. J Appl Physiol. 1998;85(4):1329–1336.

About the Author

Mike McKenney is an Athletic Trainer (AT) at Northeastern University in Boston, Massachusetts, where he is the Medical Coordinator for their Division I men’s ice hockey program.  Prior to Northeastern University, he served as an AT in multiple settings including secondary schools, Division I athletics and professional cycling; additionally, he worked as an AT who extends the services of a physician for a large orthopedic group.  He has also provided services for many organizations to include the Boston Marathon, USA Cycling and USA Volleyball.

McKenney is a hydration and electrolyte replacement consultant for the Atlanta Hawks of the NBA.  His professional interests include hydration, electrolyte replacement, thermoregulation in sport and postural restoration.  McKenney completed his athletic training education at Gustavus Adolphus College in Saint Peter, Minnesota and master’s degree at North Dakota State University in Fargo, North Dakota.  His graduate research was published in the February 2015 edition of the Journal of Athletic Training.

          Treating Eye Injuries   
By Mike McKenney, MS, ATC, NASM-CES

As Athletic Trainers, eye injuries are not the most common injury we treat, but when they occur, they can have sport- and life-altering results if not cared for properly.  It is estimated roughly a third of eye injuries that result in blindness are from sports-related injuries.1  Sports also account for 13 percent of penetrating ocular injuries nationwide, with the vast majority of these patients wearing no eye protection at all.1  Since Athletic Trainers are often present in environments with balls, bats, pucks and other objects moving at high velocities, it is imperative that eye injuries are treated appropriately and have proper return-to-play criteria.

One of the first things Athletic Trainers should do is create a plan for treating eye injuries.  Athletic Trainers should work with a team physician to create a referral network that includes an ophthalmologist or optometrist who can be consulted should an eye injury occur. This referral network will be highly beneficial to your patients since treatments for eye injury are highly specialized and time-sensitive.  If a severe eye injury occurs, the return-to-play criteria should include clearance from an ophthalmologist.1,2

In addition to a sound referral plan, you should also have a series of simple supplies on hand that can make evaluation of eye injuries easier for you and your team physician:1,2

- Ophthalmoscope

- Penlight

- Light source with blue or cobalt filters

- Vision chart

- Cotton-tipped swabs

- Saline

- Magnifying glass

- Eye shield

- Medications at the discretion of your team physicianInjuries resulting in blunt force trauma make up the majority of what Athletic Trainers see in a traditional setting.  However, with expansion into industrial settings, Athletic Trainers need to be prepared to recognize other types of injuries such as corneal foreign bodies and lacerations around the eyelid.  Additionally, a thorough history during a vision assessment can identify more subtle injuries such as non-traumatic retinal detachment.1,2

The behavior of athletes who wear contact lenses can create health-related issues that can negatively impact sport participation.  Athletic Trainers should make it a point to educate these individuals.  According to the FDA, improper care of contact lenses can result in "Discomfort, excess tearing or other discharge, unusual sensitivity to light, itching, burning, gritty feelings, unusual redness, blurred vision, swelling and pain."3 In order to prevent these symptoms, the FDA recommends:

- Replacing contact storage cases every 3-6 months

- Never re-use lens solution. Always discard after each use

- Do not use non-sterile water as a contact lens solution, especially tap water

- Do not use expired contact lens solution

- Do not borrow or re-use a friend''s contact storage case

- Do not sleep while wearing contact lenses unless they are specifically designed for that purpose3

In conclusion, Athletic Trainers should review policies to ensure they have an eye treatment plan in place. Furthermore, they should also educate athletes with corrected vision on proper care of contact lenses.

Resources:

1. Cass, SP. Ocular injuries in sports. Head and Neurological Conditions. 2012;11(1):11-15

2. Pujalte, GGA. Eye injuries in sports. Athletic Therapy Today. 2010;15(5):14-18

3. Food and Drug Administration: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048893.htm

          Acne Treatment   
Acnezine uses patented “Acne Targeting” technology and only uses clinically-proven ingredients that are third-party tested, and crafted in FDA approved labs. In short, you’re getting the best ingredients that the experts know work for people just like you.
          Senior Software Development Manager - Illumina - Singapore   
Experience in biotech is a plus, as is experience with developing SW to FDA clinical standards. Senior Manager Software....
From Illumina - Fri, 30 Jun 2017 12:44:08 GMT - View all Singapore jobs
          FDA Tobacco Enforcement Inspector - Commonwealth of Massachusetts - Boston, MA   
Possess a valid Massachusetts Motor Vehicle Operator’s License. Maintain communication with State Program Coordinator and/or Backup State Program Coordinator... $49,990 - $71,260 a year
From Commonwealth of Massachusetts - Fri, 30 Jun 2017 15:54:19 GMT - View all Boston, MA jobs
          Critics urge FDA rethink on stomach-draining weight loss device   
Critics of a newly approved weight loss device that uses a tube inserted into the stomach to drain food after a meal say it could lead to dangerous eating disorders. Advocates argue it's a less invasive option to bariatric surgery and a powerful new weapon in the global fight against obesity. Ben Gruber reports.

          Reader recommends magic mushrooms to prevent cluster headaches   

Joe and Teresa Graedon caution that the FDA considers psilocybin a Schedule I drug, meaning that it has no currently accepted medical use. Meanwhile, other readers have questions about thyroid and diabetes meds.
          Меланья Трамп избавляет Белый дом от продукции Монсанто   

Хотя публичные дебаты о безопасности генетически модифицированных продуктов питания еще в разгаре, Маланья Трамп говорит, что лучше избегать ГМ-продуктов, сообщает "Food Democracy Now".

"Здоровье Баррона улучшилось, поскольку мы начали есть органические не генетически модифицированные продукты питания", сказала первая леди.


После того как генетически модифицированная кукуруза компании Монсанто появилась в ее семье и она стала беспокоиться по поводу потенциальных негативных последствий для здоровья, Меланья Трамп сказал, что она была "поражена местом, которое эта компания занимает в пищевой цепи".

Первая леди, которая гордо описывает себя как "круглосуточная мама", затем осознала, что Монсанто производит и другие генетически модифицированные сельскохозяйственные культуры, например, сою, сахарную свеклу и хлопок и эти продукты образуют основу диеты многих американцев.

В интересах здоровья своего сына Баррона а также своего собственного, Меланья решила избавить своей семейный дом от обработанных пищевых продуктов, содержащих генетически модифицированные культуры.

Но как объяснила Меланья, это было не так просто, как кажется. По данным производителей пищевых продуктов США от 70 до 80 процентов американских переработанных продуктов питания содержат генетически модифицированные ингредиенты.

Хотя FDA пытается убедить всех, что ГМО-продукты являются безопасными, ученые, работающие на агентство, неоднократно предупреждали что верно и обратное.

Эти смелые ученые FDA выступают против официальной линии компании, которая окружила американцев коррумпированными начальниками, неоднократно предупреждая, что ГМ-продукты могут послужить появлению непредсказуемых и трудно обнаруживаемых побочных эффектов, включая аллергию, токсины, новые заболевания и проблемы с пищеварением. Они настоятельно призывают к долгосрочным исследованиям на безопасность, но агентство это проигнорировало.

Меланья говорит, что для того, чтобы принять решение ей пришлось провести много исследований.

"У меня есть друг, который является сторонником безопасного питания и я связалась с десятками продовольственными производителями и узнала, как они получают свою продукцию", сказала первая леди.

"Я потратила много времени на фермерские рынки, спрашивая фермеров о том, с какими семенными компаниями они работают, гугля на моем телефоне, прежде чем сделать покупки. Потребовалось несколько месяцев, но мне, наконец, удалось полностью убрать Монсанто из моей жизни".

Меланья Трамп говорит, что после того, как вы обучите себя и затем сделаете усилия, чтобы избежать Монсанто, вы найдете спокойствие и улучшите здоровье вашей семьи.


(http://gmoobzor.com/stati...)
          Energy Drinks Are Deadly for Young People   
Energy drinks have a lot more caffeine than coffee, and it's easy to overdo it.

We’ve all been there. Making a late-night trip to the gas station to pick up that miracle elixir—Red Bull, Monster, 5-Hour Energy—guaranteed to help you stay awake and reach your deadline. At the time, the reward seems worth the effort. But have you considered the potential cost?

That’s the question a South Carolina family is facing after recently losing their 16-year-old son. Davis Cripe collapsed in class after drinking an energy drink, a large Mountain Dew and a latte, and later died. The local county coroner, Gary Watts, said his heart was unable to cope with the amount of caffeine. "These drinks, this amount of caffeine, how it's ingested, can have dire consequences and that's what happened in this case," Watts told CBS news.

Cripe is not the first teen to fall victim to the ill effects of energy drinks. From 2005 to 2011, reported the Washington Post, trips to the emergency room due to energy drink-related issues rose from 1,494 to 20,783. A concerning number of these visits involved children under 6.

Another statistic from American Heart Association research shows that between 2010-2013, over 5,000 people contacted U.S. poison control centers due to sickness caused by energy drinks. Over half were children who experienced seizures, irregular heart rhythms or dangerously high blood pressure because they weren’t aware of the dangers posed by the high caffeine content in energy drinks 

By law, nutrition labels are not required to include information related to caffeine content. This is a problem when you consider that many varieties of energy drink contain “a lot more caffeine that an 8-ounce cup of coffee,” said Consumer Report’s deputy health editor Gayle Williams. Energy drinks are commonly marketed to children, with consumption of these beverages “increasing dramatically in the last two decades,” according to a study conducted by the International Journal of Health Sciences.

Another 2015 study published in the journal Beverages further linked this trend to health complications. “Young consumers are at a particularly high risk of complications due to hazardous consumption patterns, including frequent and heavy use,” concluded the study’s authors. 

Multiple efforts have been mounted in recent years to address this situation. Back in 2011, the American Academy of Pediatrics released a report that explicitly stated, “energy drinks pose potential health risks because of the stimulants they contain, and should never be consumed by children and adolescents.” Two years later, the American Medical Association adopted a policy that supported a ban on marketing energy drinks to children under 18 years of age. But has it made any difference?

The short answer is no. The Food and Drug Administration did manage to impose a 71-milligram limit on the amount of caffeine in a 12-ounce soda, but failed to apply this same requirement to energy drinks. The FDA has not justified this regulatory distinction, which is worsened by the fact that energy drinks aren’t required to provide labels carrying their caffeine content.

“Children, young adults and their parents should be aware of the potential hazards of energy drinks,” wrote the authors of the study published in Beverages. The authors made several suggestions regarding ways consumers, and more ambitiously, federal regulators can address this problem. 

  • “Physicians should routinely inquire about energy drink consumption in relevant cases, and vulnerable consumers such as young persons should be advised against heavy consumption, especially with concomitant alcohol or drug ingestion,” they wrote.
  • A series of public education campaigns to demystify some of the bold claims made by energy drinks (e.g. boasts of “improved physical, or cognitive performance") and make consumers more aware of the potential health hazards.
  • An eventual limit to the actual caffeine content of energy drinks and implementation of a legal age limit.
  • Prevent brands from marketing energy drinks to young people of all ages. 

Overall, the problem and the solution both come down to transparency. Consumers are largely still unaware of the caffeine content in energy drinks, and the risks posed by drinking these beverages in large quantities. With better labeling, it may be possible to reduce the number of energy drink-related emergency room visits.

 

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          Regulatory Affairs Associate III, Pre Approval - Teva Pharmaceuticals - Parsippany, NJ   
Interacts with FDA and all Teva sites via written and phone communications. Interpersonal Demonstrates ability to establish sound professional relationships...
From Teva Pharmaceuticals - Fri, 31 Mar 2017 16:03:18 GMT - View all Parsippany, NJ jobs
          Regulatory Affairs Director with a Global Top 20 Biotech company - Team leading or GRL role covering EU & FDA Liaison and Strategy - Brussels    
Job Title: Regulatory Affairs Director with a Global Top 20 Biotech company - Team leading or GRL role covering EU & FDA Liaison and Strategy - Brussels
Salary: Negotiable
Benefits: On Application
Location: Belgium, BELGIUM with Relo
Company: Advanced Regulatory (UK & Europe)
Posted: 30 June 2017
Expiry: 30 July 2017
Summary: These are great roles with a great company, offering excellent salaries and full re-location packages. The culture here is one of visibility and real product responsibility but with real regulatory support operational and strategic support available. Contact Theo Moore on +44 207 801 3384 or email your CV in confidence to CV@advregulatory.com
          Comment on Best Essential Oils for Autism and ADHD – The Ultimate Guide by Skeptical Steve   
Why do you recommend essential oils as therapy for autism, when there is no evidence to support this? This is one of the reasons DoTerra received a FDA waring letter in 2014, because their MLM sales people were claiming that it could treat autism. This claim is against DoTerra's own guidelines (revised since the FDA warning).
          One Company's Mission to Transform Sports Nutrition For Student Athletes   
Beyond new product releases, Relander has big plans for X1 Fuel’s future. Image courtesy of Rebekkah Jane Photography.

Beyond new product releases, Relander has big plans for X1 Fuel’s future. Image courtesy of Rebekkah Jane Photography.

Two years ago, Brett Relander was on the hunt for a nutrition solution to supplement his son’s sports-infused lifestyle. Staring at the shelves, Relander was frustrated—and a little taken aback—to find the market saturated with junk: fruit snacks, “granola” bars and sugar-laden drinks. He noticed “the Goldfish and Gatorade diet” on the sidelines of his son’s games, too.

For Relander, who holds a degree in Exercise Science and is a father of three, this didn’t sit well. The idea to launch a product with the right balance of taste and nutrition began to take shape.

“It was a lightbulb moment,” he recalls. “I felt like it was my calling.”

In February, Relander saw phase one of his project come to life with the launch of X1 Fuel, a sports nutrition company dedicated to helping student athletes achieve their full potential.

Fueling Active Lifestyles

Relander’s career has primarily focused on marketing over the past decade, but he’s kept his passion for kids and sports alive: Back in 2000, he interned at the prestigious CooperAerobics Center, and he’s coached countless kids’ sports teams over the years. Today, he’s dedicated to making sports nutrition his primary focus. He’s bootstrapped X1 Fuel using a $300,000 credit line from a hometown bank, and hopes to continue growing the company as well as its product offerings.

“To get back to something that I’m really passionate about is a dream come true,” says Relander.

X1 Fuel recently released two powder-based products—one for pre-training and one for recovery—that can be mixed with water before and after workouts for easy, on-the-go nutrition.

The journey hasn’t been without its challenges, though: Finding a reliable manufacturer that would meet X1 Fuel’s high standards proved elusive for months. Finding the right mix of ingredients, too, was a lengthy process. Ultimately, Relander decided on an all-natural superfood mix high in antioxidants and taste-tested by kids as young as six. The recipe contains no GMOs, gluten, caffeine or artificial sweeteners.

Relanders’ own kids use the products, and they certainly need the fuel: His 6-year old daughter packs in nine hours of gymnastics every week, and his son is as active as ever, playing basketball, volleyball, and year-round soccer for the FC Dallas club.

One of the most crucial elements of post-exertion recovery for kids, says Relander, is getting replenishment within 30 minutes of working out. This can be difficult or impossible after a game or practice, since it often takes families as long just to drive home. X1 Fuel addresses the issue of nutrition on the go: Each product order comes with a shaker bottle with two compartments, so it’s easy to take anywhere.

“Whether these athletes’ workouts are an hour or three hours long, we want to make sure they’ve got the energy available from a quality source—not just from loading up on sugar,” explains Relander.

Though X1 Fuel looks like something you might find in the supplement aisle, the products are classified as food—and are manufactured in an FDA registered and inspected facility. Transparent labeling, says Relander, such as the products’ clearly stated Nutrition Facts, is key.

“It was a little bit more expensive and time-consuming from a regulation perspective, but it was the right path to go down,” says Relander. “We want to build trust with our customers; we want them to know that what they read on our labels is true.”

The payoff has been promising: From March to April, the company saw sales double, and they are on track to double again in May. Recently the products also received certifications from Informed-Choice, an organization that tests for banned substances (of which X1 Fuel contains none). These certifications, says Relander, will help X1 Fuel “take its place within the sports nutrition market.”

Core Values that Go Beyond Nutrition

Beyond new product releases, Relander has big plans for X1 Fuel’s future.

He’ll accomplish these goals in part through the company’s partner program, which consists of a network of coaches and sports professionals who act as brand ambassadors. A few of the notable names who have joined the “X1 Family” to date include: Darrin Morris, an international rugby player and World Cup international coach; Eve Pearson, a registered sports dietician and owner of Nutriworks; Scott Sealy, a former FC Dallas professional soccer player; Justin Musil, president and founder of Elite Sports Advertising; and Brad Prichard, a high school basketball coach and owner of Prichard Performance. Relander personally vets each partner to make sure they fit the brand’s overarching vision.

It’s not just nutrition that X1 is aiming to disrupt: He hopes to use X1 Fuel’s core values—CHOOSE the positive, GIVE your best, RECOGNIZE achievement—as a foundation for a leadership training program that will address student athletics from a holistic perspective.

“There are plenty of physical training resources, but not a lot of people talk about the mental side,” explains Relander. “I want student athletes to understand that when they get up in the morning, it’s their choice to be positive—whether on the court, on the field, at home, at work, wherever.” To help spread his message Relander plans to host events for student athletes that focus on leadership, visualization, sportsmanship, social media best practices for athletes, and the mental side of sports.

Relander plans to take 100% of the ticket sales for these events to fund a scholarship program for student athletes. The proceeds will help lower-income families afford the expenses of recreational athletics for their kids—everything from club fees to cleats. In turn, the program will help strengthen student athlete communities around the country.

At the end of the day, it all comes down to supporting the kids. The juice is worth the squeeze, so to speak, when Relander sees how X1 Fuel is helping young people live more active, healthier lives.

From a dad’s perspective, especially, Relander is aware of how crucial it is to keep kids active in an era of screens and smartphones. (His daughter, he says, knew how to handle a smartphone at the age of one.) Sports helped shape who he is today, and Relander’s hope for X1 Fuel is that it will help kids make the most of the valuable lessons they can learn out on the field (or on the court, in the gym, etc.).

“Sports, to me, are a way to get kids active, get them outdoors, get them learning about dedication and teamwork. Sports help kids learn about being accountable to teammates—and about making a commitment and seeing it through.”

Which is exactly what Relander plans to do with X1. He hopes to take the company beyond physical products and make it into more of a movement: “We want people who care about the kids.” he says. “We want to get as many people involved in the X1 Family who share our values as possible. It’s about purpose.”


          Ideas to Don’t forget Although Acquiring Apettite supressants 37.5 milligram Weight-loss Products On the internet   

Apettite supressant 37.5 mg  is an eating plan suppressant substance that is approved by the Food, but it’s a manipulated drug. The FDA claims that it shouldn’t be used for over a dozen days. Because Apettite supressants 37.5 milligram  is a governed medicine, you’ll find few sites that market the medicine, due to the numerous legal issues included. Nonetheless, there are many websites that are available legal, health professional prescribed obtained drug treatments. Here are some ideas to keep in mind while buying Apettite supressants 37.5 milligrams  via these websites http://phentermine.tv-gossip.com.
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In case you are getting Apettite supressant 37.5 milligram  online, you can even examine out the place that the share is originating from. Many websites that market medicines provide a lot of information about themselves, from the comfort of about wherever they obtain drugs from to where one can purchase …


          Research and QC Technician   
RI-Providence, Research and QC Technician Rapidly growing diagnostic manufacturer seeking a Research and QC Technician with keen attention to detail required by FDA guidelines. Ideal candidate will be proficient in Excel, possess strong analytical and organizational skills, and able to multi-task while meeting deadlines. Applicant will be trained on medical laboratory analysis and responsible for managing data.
          Wedding Cake Topper EDIBLE Butterflies -12 Small Greens - Edible Butterfly Wedding Favors - Edible Butterfly Cupcake Topper by SugarRobot   

4.95 USD

*Please read shipping & policies info before you place your order for estimated shipping and delivery times

-Lifelike butterflies are completely edible!

-You will receive 12 assorted green butterflies

-Wing spans vary from 1.5 inches - 1.75 inches

-Precut and Ready to Use

-Made of wafer paper (potato starch, vegetable oil, water) and food color. FDA approved print. Brushed with organic vanilla

-Use a dab of regular frosting or corn syrup to adhere to most food items, wine glasses, and serving dishes. Fold up the wings on either side of the body for a fluttering effect.

-Use within 4 months of receiving them. Store in the packaging they arrive in. Each item is sealed for optimum freshness. Do not refrigerate.


★★★★ All Items are Gluten Free and 100% Vegan ★★★★
Although there are no nuts in the ingredients - Sugar Robot's production facilities are NOT a tree nut free environment


Edible Butterflies © are Copyright protected.....Any persons found in violation will be sentenced to the basement and fed to our Copyright Monster (grrrr) - no really, they are protected*Please read shipping & policies info before you place your order for estimated shipping and delivery times


          Implications and challenges for implementation of the FDA's final deeming rule for waterpipe tobacco.   

Implications and challenges for implementation of the FDA's final deeming rule for waterpipe tobacco.

Tob Control. 2017 Jun 30;:

Authors: Sutfin EL, Soule EK, McKelvey K, Jenson D

Abstract
For the first time, the Food and Drug Administration's (FDAs) Center for Tobacco Products now has regulatory authority over all tobacco products, including waterpipe tobacco. In the rule expanding its authority to cover all tobacco products, the FDA uses largely a one-size-fits-all approach. However, several aspects of waterpipe tobacco smoking make it unique from other tobacco products, which may require more specific, tailored rules. This paper describes the distinct features of waterpipe tobacco products and accessories, and identifies unique challenges to the current regulation posed by this form of tobacco use. Additionally, we highlight the need for further research-generated evidence to support additional rulemaking.

PMID: 28667092 [PubMed - as supplied by publisher]


          FDA Reviews Previously Denied Drug Applications   
Stocks are soaring for pharmaceutical companies as the FDA looks at easing regulatory restrictions for bringing new drugs to market. Even better for Big Pharma, the FDA will review drug applications that were denied in the past. But there are m...
          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          FDA Tobacco Enforcement Inspector - Commonwealth of Massachusetts - Boston, MA   
Possess a valid Massachusetts Motor Vehicle Operator’s License. Maintain communication with State Program Coordinator and/or Backup State Program Coordinator... $49,990 - $71,260 a year
From Commonwealth of Massachusetts - Fri, 30 Jun 2017 15:54:19 GMT - View all Boston, MA jobs
          Stopping Premature Ejaculation - Two Free Tips On Stopping Premature Ejaculation   
fda warning about stamina rx: Premature ejaculation is a devastating problem for men all over the world. Did you know that it takes the average woman twenty minutes of active sexual intercourse to reach orgasm? If you are the type of guy that is lucky to break the three-minute... Stopping Premature Ejaculation
          Physician Director - Step Up Skin Laser - Sunny Isles, FL   
We are currently seeking physician to be a director to our FDA approved diode laser machine and to our multiple medical laser spa in or Miami location....
From Indeed - Sat, 15 Apr 2017 23:06:22 GMT - View all Sunny Isles, FL jobs
          Sr. Quality Assurance Engineer – DNA Electronics, Inc. – Carlsbad, CA   

5-7 years of experience as a Quality Engineer in an FDA and/or ISO regulated environment in IVD, medical device, or biotech industry....From Indeed - Fri, 30 Jun 2017 22:15:06 GMT - View all Carlsbad, CA jobs

The post Sr. Quality Assurance Engineer – DNA Electronics, Inc. – Carlsbad, CA appeared first on San Diego Biotechnology Network.


          FDA 批准安进 Vectibix 治疗 RAS 野生型结直肠癌   
近日,美国安进制药公司表示,美国 FDA 已经就公司 Vectibix® (panitumumab) 的补充生物制品许可申请(sBLA)给予了批准的决定。Vectibix 被批准联合 FOLFOX 用于 RAS 野生型(指的是 KRAS 及 NRAS 经 FDA 批准的检测设备确定为野生型)的转移性 阅读全文
          3D inkjet printing of tablets exploiting bespoke complex geometries for controlled and tuneable drug release.   

3D inkjet printing of tablets exploiting bespoke complex geometries for controlled and tuneable drug release.

J Control Release. 2017 Jun 28;:

Authors: Kyobula M, Adedeji A, Alexander MR, Saleh E, Wildman R, Ashcroft I, Gellert PR, Roberts CJ

Abstract
A hot melt 3D inkjet printing method with the potential to manufacture formulations in complex and adaptable geometries for the controlled loading and release of medicines is presented. This first use of a precisely controlled solvent free inkjet printing to produce drug loaded solid dosage forms is demonstrated using a naturally derived FDA approved material (beeswax) as the drug carrier and fenofibrate as the drug. Tablets with bespoke geometries (honeycomb architecture) were fabricated. The honeycomb architecture was modified by control of the honeycomb cell size, and hence surface area to enable control of drug release profiles without the need to alter the formulation. Analysis of the formed tablets showed the drug to be evenly distributed within the beeswax at the bulk scale with evidence of some localization at the micron scale. An analytical model utilizing a Fickian description of diffusion was developed to allow the prediction of drug release. A comparison of experimental and predicted drug release data revealed that in addition to surface area, other factors such as the cell diameter in the case of the honeycomb geometry and material wettability must be considered in practical dosage form design. This information when combined with the range of achievable geometries could allow the bespoke production of optimized personalised medicines for a variety of delivery vehicles in addition to tablets, such as medical devices for example.

PMID: 28668378 [PubMed - as supplied by publisher]


          Comment on IMPLANTES MAMARIOS APROBADOS POR LA FDA (JUNIO 2013) by Dr. Guilarte   
Buenos días Alejandra, desconozco cuál es esta marca de implantes. Muchas gracias. Un saludo.
          Comment on IMPLANTES MAMARIOS APROBADOS POR LA FDA (JUNIO 2013) by Alejandra   
Buenas me.voy a operar y me.estan vendiendo los implantesnarca kangning, me puede decir que tal.son?
          (USA-CO-Littleton) Quality Engineer I - 170000KU   
JOB SUMMARY:The Quality Engineer is responsible for focusing engineering quality asregulated by the FDA and other competent authorities. This position isresponsible for supporting the execution of quality processes in accordancewith the quality system.PRIMARY JOB FUNCTIONSAssist in the supporting manufacturing actives in accordance with therequirements of USFDA CFR 820 and ISO 13485Participating on project teams as a contributing member by providing qualityengineering support in the development and continuous improvement of 3DSystems' Healthcare products and processes.Contributing to the development and execution of verification & validationplans, testing, and generation of test reportsDevelopment and contribution to the risk management processAssisting project teams on compliance with design control requirements per FDAQSR, European MDD, ISO 13485 and other applicable ISO/EN standardsMaintaining current knowledge of FDA and international regulation, guidanceand standards applicable to company productsFacilitating and performing internal QA audits as requiredParticipating in the execution, maintenance and improvement of the QualityManagement System.Analyzing reports and returned products and recommendingcorrective/preventive actions (CAPAs)Performing statistical analysis to assess cost of, and determining theresponsibility for products or materials that do not meet required standardsand specificationsEducation and TrainingBS degree in engineering or related field is preferredExperience0-2 years of related work experience in regulated, cGMP environment such asmedical device, pharmaceutical or food manufacture.Knowledge, Skills & AbilitiesQuality assurance and reliability experience supporting product developmentand/or manufacturing are preferred.Working knowledge of GMP and ISO 13485 Quality SystemAbility to read and design engineering specifications across a number ofproducts and materials.Ability to analyze and develop engineering processes for use in advancedtechnology implementations.Experience in preparing technical documentation.VEVRAA Federal ContractorRequest Priority Protected Veteran ReferralsEOE -Veteran /Disabled/Minority/AA/F/M/SO
          PasarDino - DINOMARKET.com : Jual Dermapen K-Med Tech   
in Category : Health & Beauty


(PasarDino - DINOMARKET.com) - DERMAPEN (model recharge) Made in Korea Power Supply : pengisian Adapter : 4.2v 500mA- Frekuensi bergetar : 6500-8500r / m Timbang : 56g tubuh utama Warna : silver atau biru Ukuran : 14.5cm 5 kecepatan tingkat getaran yang dapat dikendalikan Jarum lehgth: dari 0.25mm ke 2.0mm disesuaikan Perangkat jarum yang bekerja untuk mengencangkan, mengangkat dan meremajakan kulit. Ini adalah perangkat elektronik oleh FDA menggunakan beberapa jarum halus vertikal untuk menembus kulit. Prosedur in...
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selengkapnya »
          BRIEF-India's Strides Shasun gets U.S. FDA approval for Promethazine Hydrochloride tablets   

July 3 (Reuters) - Strides Shasun Ltd:

* Says co gets U.S. FDA approval for PromethazineHydrochloride tablets

* Product to be manufactured in co's facility in Bangaloreand marketed by Strides Pharma in the U.S. market

* Promethazine Hydrochloride tablet is used to prevent andtreat nausea and vomiting related to certain conditions

Source text - http://bit.ly/2sCRQzU

Further company coverage:


          FDA Tobacco Enforcement Inspector - Commonwealth of Massachusetts - Boston, MA   
Possess a valid Massachusetts Motor Vehicle Operator’s License. Maintain communication with State Program Coordinator and/or Backup State Program Coordinator... $49,990 - $71,260 a year
From Commonwealth of Massachusetts - Fri, 30 Jun 2017 15:54:19 GMT - View all Boston, MA jobs
          Horizon Discovery announces inclusion of its Reference Standards in successful FDA approval of an oncology companion diagnostic test with leading next generation sequencing company   
none
          Regulatory Affairs Associate III, Pre Approval - Teva Pharmaceuticals - Parsippany, NJ   
Interacts with FDA and all Teva sites via written and phone communications. Interpersonal Demonstrates ability to establish sound professional relationships...
From Teva Pharmaceuticals - Fri, 31 Mar 2017 16:03:18 GMT - View all Parsippany, NJ jobs
          Any Drug Manufacturer (or Repackager, Dispenser, and Distributor) Affected by the Looming Serialization Deadline in the Drug Supply Chain Security Act Really Should Read This One.....   
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          Regulatory Affairs Associate III, Pre Approval - Teva Pharmaceuticals - Parsippany, NJ   
Interacts with FDA and all Teva sites via written and phone communications. Interpersonal Demonstrates ability to establish sound professional relationships...
From Teva Pharmaceuticals - Fri, 31 Mar 2017 16:03:18 GMT - View all Parsippany, NJ jobs
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NEW YORK (AP) — Dairy farmers need U.S. regulators to banish the time period “soy milk,” however paperwork present even authorities businesses haven’t all the time agreed on what to name such drinks. The U.S. Division of Agriculture “fervently” needed to make use of the time period “soy milk” in instructional supplies for the general public, in response to emails lately launched in response to a lawsuit. That irked the Meals and Drug Administration, the company that oversees the federal rule defining milk as coming from wholesome cows. It’s “not a trivial choice,” the FDA warned in one of many

The post Soy ‘milk’? Even federal agencies can’t agree on terminology appeared first on NB.


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          Energy Drinks Are Deadly for Young People   
Energy drinks have a lot more caffeine than coffee, and it's easy to overdo it.

We’ve all been there. Making a late-night trip to the gas station to pick up that miracle elixir—Red Bull, Monster, 5-Hour Energy—guaranteed to help you stay awake and reach your deadline. At the time, the reward seems worth the effort. But have you considered the potential cost?

That’s the question a South Carolina family is facing after recently losing their 16-year-old son. Davis Cripe collapsed in class after drinking an energy drink, a large Mountain Dew and a latte, and later died. The local county coroner, Gary Watts, said his heart was unable to cope with the amount of caffeine. "These drinks, this amount of caffeine, how it's ingested, can have dire consequences and that's what happened in this case," Watts told CBS news.

Cripe is not the first teen to fall victim to the ill effects of energy drinks. From 2005 to 2011, reported the Washington Post, trips to the emergency room due to energy drink-related issues rose from 1,494 to 20,783. A concerning number of these visits involved children under 6.

Another statistic from American Heart Association research shows that between 2010-2013, over 5,000 people contacted U.S. poison control centers due to sickness caused by energy drinks. Over half were children who experienced seizures, irregular heart rhythms or dangerously high blood pressure because they weren’t aware of the dangers posed by the high caffeine content in energy drinks 

By law, nutrition labels are not required to include information related to caffeine content. This is a problem when you consider that many varieties of energy drink contain “a lot more caffeine that an 8-ounce cup of coffee,” said Consumer Report’s deputy health editor Gayle Williams. Energy drinks are commonly marketed to children, with consumption of these beverages “increasing dramatically in the last two decades,” according to a study conducted by the International Journal of Health Sciences.

Another 2015 study published in the journal Beverages further linked this trend to health complications. “Young consumers are at a particularly high risk of complications due to hazardous consumption patterns, including frequent and heavy use,” concluded the study’s authors. 

Multiple efforts have been mounted in recent years to address this situation. Back in 2011, the American Academy of Pediatrics released a report that explicitly stated, “energy drinks pose potential health risks because of the stimulants they contain, and should never be consumed by children and adolescents.” Two years later, the American Medical Association adopted a policy that supported a ban on marketing energy drinks to children under 18 years of age. But has it made any difference?

The short answer is no. The Food and Drug Administration did manage to impose a 71-milligram limit on the amount of caffeine in a 12-ounce soda, but failed to apply this same requirement to energy drinks. The FDA has not justified this regulatory distinction, which is worsened by the fact that energy drinks aren’t required to provide labels carrying their caffeine content.

“Children, young adults and their parents should be aware of the potential hazards of energy drinks,” wrote the authors of the study published in Beverages. The authors made several suggestions regarding ways consumers, and more ambitiously, federal regulators can address this problem. 

  • “Physicians should routinely inquire about energy drink consumption in relevant cases, and vulnerable consumers such as young persons should be advised against heavy consumption, especially with concomitant alcohol or drug ingestion,” they wrote.
  • A series of public education campaigns to demystify some of the bold claims made by energy drinks (e.g. boasts of “improved physical, or cognitive performance") and make consumers more aware of the potential health hazards.
  • An eventual limit to the actual caffeine content of energy drinks and implementation of a legal age limit.
  • Prevent brands from marketing energy drinks to young people of all ages. 

Overall, the problem and the solution both come down to transparency. Consumers are largely still unaware of the caffeine content in energy drinks, and the risks posed by drinking these beverages in large quantities. With better labeling, it may be possible to reduce the number of energy drink-related emergency room visits.

 

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