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Pink Sheet Podcast: Makena Hearing Take-Aways, Industry’s Accelerated Approval Failings, US FDA Claims Enforcement

Executive Summary

Pink Sheet reporters and editors discuss lessons from the public hearing on the proposed withdrawal of the preterm birth prevention drug Makena, FDA Commissioner Califf’s opinion that industry is not meeting expectations with accelerated approval confirmatory studies, and agency efforts to clarify that staff is paying attention to comparative claims in product ads.

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