: This is part I of a two-part column on the Food and Drug Administration approval process.
Last year, this column
highlighted the debate around drug and device safety. At that time, I expected that the controversy would continue to grow.
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6 congressional hearing, Waxman stated, The FDA never required the manufacturer to [conduct] a thorough post-market study of Avandia's heart risks, noting that the FDA requires such safety studies after drugs are approved.
Safety takes a back seat
As pointed out in previous columns, safety has always been a concern ever since Hippocrates laid out the dictum of First, Do N......Full article >>>
ewise, in using drugs or devices for preventive purposes, safety becomes that much more important. It's hard to justify a safety risk in the context of a condition with no symptoms.
As the Avandia story reached the front pages, a number of related side stories also appeared. One recent report
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standard for drug approval is demonstrated efficacy - namely that the drug works. Safety also is a part of the process and ordinarily there are fairly extensive preclinical and animal studies designed to ferret out unsafe drugs. Most of these studies are fairly routine safety tests that simply set the backdrop to the real clinical trials that are of large enough size, or are of clever enough desig......Full article >>>
Ogan Gurel: Abbott vs. Thailand has implications for innovation and access
Ogan Gurel: Personalized medicine and technology convergence
Of private equity, research, and drug development
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Source:wistechnology.com By Dr. Ogan Gurel 06/20/07Related biology technology :1
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