FDA Fast-Track Program May Harm Patient Safety, Study Says

Law360, New York (September 5, 2012, 8:40 PM EDT) -- The U.S. Food and Drug Administration's decision to fast-track drugs made by AstraZeneca PLC, Novartis Pharmaceuticals Corp. and Boehringer Ingelheim GmbH for approval may have unduly risked patients' safety, according to a medical journal article published Wednesday.

In an article in the Journal of the American Medical Association, two researchers examined the safety records of three drugs approved under at least one of three FDA programs designed to speed up review times: priority review, accelerated approval and the fast track program. The initiatives were created to...
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