Do Drugs Given Expedited Approval Have More Safety Risks? GAO Says FDA Can't Tell

Findings could give pharmacovigilance prominence alongside 'breakthrough' and other speed mechanisms in legislative debate on agency reform.

The Government Accountability Office (GAO) gave FDA a negative report card on its postmarket oversight of drugs approved with a fast track or breakthrough therapy designation, finding the agency's data on safety issues for these drugs is unreliable and difficult to access.

FDA needs a plan to correct the problem, GAO concludes in the

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