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Definition: FDA Approval


The Food and Drug Administration - FDA is US Department of Health and Human Services authority responsible for regulating and supervising the safety of foods, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.

FDA does not regulate non safety related approvals - the FDA regulates prescription drugs, testing, manufacturing, labeling, advertising, marketing, efficacy and safety, however FDA regulation of cosmetics is focused primarily on the safety aspects of labeling.

The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency however FDA authority and regulation is recognised as the pre-eminent authority of its type in most countries of the western world.













 


Teva set to resume production
News-Press Now
It was unclear how many workers Teva would be bringing back following the FDA approval. The St. Joseph operations have been upgraded, creating a state-of-the-art work center for Oral Liquid Drug products and shampoos, flushes and sprays.

02/07/2012 06:45 AM


4 Biotech Stocks To Buy, 1 To Avoid For Now
Seeking Alpha
By Mark Goldstein The biotech sector has always been risky due to the fact that its product pipeline is affected by FDA approval and risks in the development of products. At the same time, this sector is driven by many catalysts, including key ...

and more »

02/06/2012 09:31 PM


Merck Investors Can Sleep Easier (Not Easy)
DailyFinance
Sanofi (NYS: SNY) failed to get FDA approval of its sleeping aid Ciltyri a few years ago because the risk-benefit profile was out of whack, causing the French pharmaceutical company to eventually to give up on the molecule. On the other hand, ...
Merck Will Seek FDA Approval for Insomnia Drug (MRK)24/7 Wall St.

all 54 news articles »

02/06/2012 08:43 PM


Fact Finder: Cold Laser Therapy and it's many uses
Alabama's13.com
Without FDA approval, insurance typically won't pay for its use, but Cold Laser Therapy is increasing in popularity. Today it's being used in the treatment of allergies, pain and for weight loss. (more) Cold lasers come in different sizes, ...

02/06/2012 08:25 PM


VuCOMP Gets FDA Approval for Mammo CAD System
Diagnostic Imaging
By Diagnostic Imaging Staff | February 6, 2012 Computer-aided detection system developer VuCOMP Inc. has received FDA premarket approval for its film mammography CAD software. This is the first new mammography CAD system approved by the FDA since 2007, ...

02/06/2012 07:28 PM


California clinic to perform stem cell procedure amid FDA lawsuit
BioNews
Regenerative Sciences counter that because stem cells are produced by the body, they are not drugs, so the treatment does not need FDA approval. The group claims to have treated more than 1000 patients and spent over $500000 on testing.

02/06/2012 03:17 PM










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