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CDER To Pilot Test New Framework For Classifying Drug Safety Issues

Executive Summary

A recent draft guidance spells out the agency’s proposed approach to classifying significant post-marketing safety concerns for “standard,” “priority” or “emergency” handling. After pilot testing the framework over the next year, CDER intends to develop milestones for regulatory action on safety issues, similar to NDA/BLA action dates under PDUFA.

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