FDA fails to adequately monitor post-market drug safety, says report

15 January 2016

The US Food and Drugs Administration is failing to adequately monitor the safety of new drugs approved through its accelerated approval process, a US government report has revealed.

An investigation by the US Government Accountability Office (GAO), a non-partisan unit of Congress, found numerous flaws in the FDA’s system for tracking drug safety issues, including incomplete, outdated and inaccurate information.

Safety reviews on drugs that have used fast-track approval programs are crucial to identify potential issues that may have been missed during the approval process.

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