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CDER To Pilot Test New Framework For Classifying Drug Safety Issues

 
• By Sue Sutter

A recent draft guidance spells out the agency’s proposed approach to classifying significant post-marketing safety concerns for “standard,” “priority” or “emergency” handling.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.

The Center for Drug Evaluation and Research’s upcoming pilot test of a new system for prioritizing action on post-marketing drug safety issues will lead to the development of regulatory milestones – an approach akin to user fee goal dates in the pre-market setting.

Within the next year, CDER will begin implementing a framework for ensuring that certain kinds of post-marketing safety issues receive...

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