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Medical News and Perspectives
October 27, 2010

Oversight of Fast-Track Drug Approval by FDA Stuck in Low Gear, Critics Say

JAMA. 2010;304(16):1773-1775. doi:10.1001/jama.2010.1486

Since 1992, the US Food and Drug Administration (FDA) has offered an accelerated approval process designed to make available new drugs to treat dire conditions that lack alternative therapies. To achieve speed, the FDA allows approval based on a lower standard than required for the regular approval process. That laxity in initial oversight is supposed to be followed by rigorous postmarketing studies that validate the efficacy and safety of the drug.

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