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FDA Steps Up Support For Advanced Manufacturing Technologies


FDA Steps Up Support For Advanced Manufacturing Technologies
The latest article by FDA Commissioner Hahn
1 is one of a string of communications and guidances emphasizing the agency’s support for the adoption of advanced manufacturing technologies (AMTs) and processes. The FDA has defined advanced manufacturing as new and emerging approaches for the production of medical technologies that can improve drug quality, address shortages of medicines, and speed time-to-market. The agency recognizes that AMT subsumes a broad swath of production techniques, including:
The integration of novel technology approaches;
The use of established techniques in a new or innovative way;
Applying production methods in a new domain where there are no defined best practices or experiences. ....

United States , Bikash Chatterjee , Development Agreement , National Institute For Innovation , Pharmatech Associates , University Of Delaware , National Advisory Board , Technologies Program , Manufacturing National Program Office , Case For Quality Program , National Institute Of Standards , Technology Team , Radiological Health , Technologies Team , University Of California At San Diego , Collaborative Research , Technology Program , National Institute , Manufacturing Biopharmaceuticals , Advanced Manufacturing National Program Office , Drug Evaluation , Emerging Technology , Emerging Technology Team , Biologics Evaluation , Advanced Technologies Program , Advanced Manufacturing ,

FDA Steps Up Support For Advanced Manufacturing Technologies


FDA Steps Up Support For Advanced Manufacturing Technologies
The latest article by FDA Commissioner Hahn
1 is one of a string of communications and guidances emphasizing the agency’s support for the adoption of advanced manufacturing technologies (AMTs) and processes. The FDA has defined advanced manufacturing as new and emerging approaches for the production of medical technologies that can improve drug quality, address shortages of medicines, and speed time-to-market. The agency recognizes that AMT subsumes a broad swath of production techniques, including:
The integration of novel technology approaches;
The use of established techniques in a new or innovative way;
Applying production methods in a new domain where there are no defined best practices or experiences. ....

United States , Bikash Chatterjee , Development Agreement , National Institute For Innovation , Pharmatech Associates , University Of Delaware , National Advisory Board , Technologies Program , Manufacturing National Program Office , Case For Quality Program , National Institute Of Standards , Technology Team , Radiological Health , Technologies Team , University Of California At San Diego , Collaborative Research , Technology Program , National Institute , Manufacturing Biopharmaceuticals , Advanced Manufacturing National Program Office , Drug Evaluation , Emerging Technology , Emerging Technology Team , Biologics Evaluation , Advanced Technologies Program , Advanced Manufacturing ,

Artificial Pancreas on the Horizon


Artificial Pancreas on the Horizon
An artificial pancreas could revolutionize the treatment of diabetes, and it may only be a few years away.
From the WebMD Archives
For millions of people with diabetes worldwide, life is a series of fingersticks, injections, and surges and dips in blood sugar levels. But with its promise of automatically regulating a person s blood sugar, the artificial pancreas could change all that.
The artificial pancreas will revolutionize the treatment of diabetes, says Eric Renard, MD, PhD, professor of endocrinology, diabetes and metabolism at Montpellier Medical School in Montpellier, France. It will prevent diabetes complications, [which include blindness, kidney failure, amputations, heart disease, and death]. And quality of life will be tremendously improved as people won t have to be constantly pricking and monitoring themselves, says Renard, who is leading the first clinical trial of the device. ....

United States , Medtronic Minimed , Lori Hahn , Department Of Energy Lawrence Livermore National Laboratory , Becton Dickinson , Animas Corp , Technologies Program , Medical Technologies Program , Lawrence Livermore National Laboratory , ஒன்றுபட்டது மாநிலங்களில் , லோரி ஹான் , துறை ஆஃப் ஆற்றல் லாரன்ஸ் லிவர்மோர் தேசிய ஆய்வகம் , பெக்டன் டிக்கின்சன் , அனிமாக்கள் கார்ப் , தொழில்நுட்பங்கள் ப்ரோக்ர்யாம் , மருத்துவ தொழில்நுட்பங்கள் ப்ரோக்ர்யாம் , லாரன்ஸ் லிவர்மோர் தேசிய ஆய்வகம் ,