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Supplemental Filings: CBER/CDER Real-Time Comms, DCT Fall Off, Mifepristone REMS

 
• By Pink Sheet Team

US CBER director Peter Marks suggests CDER could join its real-time communications pilot program, CDER's Jacqueline Corrigan-Curay says the use of decentralized trials has declined since the pandemic eased, and the GAO concludes that revisions to the mifepristone REMS do not require congressional review.

supplemental filings
• Source: Pink Sheet illustration

Welcome to another edition of Supplemental Filings, where US-based Pink Sheet reporters offer bonus, quick-hit analysis and insight we think you should know about, but didn’t make it into full-length stories.

The US Food and Drug Administration’s Center for Drug Evaluation and Research may wind up collaborating with the Center for Biologics Evaluation and Research on a rare disease communications initiative.

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More from Pink Sheet

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