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Capitol Health Call
December 9, 2009

Postmarket Studies Lag

JAMA. 2009;302(22):2423. doi:10.1001/jama.2009.1802

The US Food and Drug Administration's (FDA’s) oversight for drugs brought to market through an accelerated approval process remains poor, reports the Government Accountability Office (GAO).

The FDA offers drug makers quick approval, based on the successful completion of trials involving surrogate end points, of certain drugs designed to treat serious or life-threatening illnesses. However, these companies are then required to conduct postmarketing studies to confirm clinical benefit.