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Safety First: FDA Unveils New Postmarketing Management Process For Safety

Executive Summary

With FDA's latest new initiatives to address problems with postmarketing safety processes -Safety First/Safe Use - the agency is aiming at applying PDUFA-style management to postmarketing drug safety issues

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CDER To Pilot Test New Framework For Classifying Drug Safety Issues

A recent draft guidance spells out the agency’s proposed approach to classifying significant post-marketing safety concerns for “standard,” “priority” or “emergency” handling.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

CDER Eyes Prioritization, Timely Resolution Of Post-Marketing Safety Issues

Now that it has a system in place to track post-marketing drug safety issues, FDA’s Center for Drug Evaluation and Research is turning its attention to setting standard timeframes for investigating and addressing such signals.

CDER Eyes Prioritization, Timely Resolution Of Post-Marketing Safety Issues

Now that it has a system in place to track post-marketing drug safety issues, FDA’s Center for Drug Evaluation and Research is turning its attention to setting standard timeframes for investigating and addressing such signals.

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