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

The US Government Accountability Office (GAO) gave the Food and Drug Administration a negative report card on its post-market 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.

The US Government Accountability Office (GAO) gave the Food and Drug Administration a negative report card on its post-market 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.

The FDA needs a plan to correct the problem, GAO concludes in the report, "Drug Safety: FDA Expedites Many Applications, But Data

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