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Reforming FDA: Focus on safety, let market judge efficacy

Editor's note: This is part II of a two-part column on the Food and Drug Administration approval process. Part I focused on the recent controversy over Avandia, GlaxoSmithKline's diabetes drug.

The primacy of efficacy over safety seems to be so deeply integral to the system that it migh......

Full article >>> terms of money and time) to generate the substantial evidence of drug efficacy.

Drug development now takes much longer. And in shifting priority from safety to efficacy, the Kefauver-Harris amendment has had the unintended consequence of slowing down drug approvals in the present era.

FDA: Tortoise or hare?

The By Ogan Gurel 06/25/07

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