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Drug Safety Communications Are Not Crisis Management Tools, FDA Says

Executive Summary

A new draft guidance explains the Center for Drug Evaluation and Research’s approach to communicating emerging drug safety information. Since 2010, Drug Safety Communications have replaced a variety of audience-focused tools laid out in a 2007 guidance, but FDA says public health alerts will be used to communicate about products that pose an immediate danger.

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FDA’s plan to permanently archive old safety communications, even after an issue has been resolved, is not aligned with the goal of informing the public about potential emerging risks, the Biotechnology Industry Organization says in comments on a recent draft guidance. Pharmacy groups want the agency’s safety communications to include more information about the data underlying a potential risk.

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A recent draft guidance spells out the agency’s proposed approach to classifying significant post-marketing safety concerns for “standard,” “priority” or “emergency” handling.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A recent draft guidance spells out the agency’s proposed approach to classifying significant post-marketing safety concerns for “standard,” “priority” or “emergency” handling.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

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