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FDA: Tortoise, hare, or something else?

Editor's note: 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.

Ind......

Full article >>> 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 ......

Full article >>> 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......

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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 06/20/07


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