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US FDA defends accelerated approvals; rejects GAO's suggestions

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration has conceded that its oversight of postmarketing studies for drugs cleared under the accelerated approval process has been inadequate in the past. But the agency has rejected a critical new government watchdog report that, it says, focuses on a limited number of drugs with which there have been problems under the process1.

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