FDA Releases Draft Guidance for Drug Safety Plans

The U.S. Food and Drug Administration has released a proposal on how it plans to handle safety issues related to marketed drugs.

Significant safety issues related to post-market drugs include serious adverse events, product quality issues and medication errors. This draft guidance seeks to establish a framework for classifying significant postmarketing drug safety issues as priority, standard or emergency.


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Once the safety issue has been prioritized, the agency can proceed with assessing the risk and taking action steps to mitigate harm, which may include label changes or voluntary withdrawal of the product. The FDA said such a framework is intended to help agency workers identify the problems that require the most urgency and attention. It is also intended to help deploy timely public drug safety communications.

The agency has opened the draft guidance to public comment.

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