Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meeting - BioSpace
β’ The FDA is meeting this Wednesday to gather input from the public and industry stakeholders for the next Prescription Drug User Fee Act, which will set agency priorities for fiscal years 2028β2032. β’ Health policy firm Aviva Strategies noted in a Friday memo that the FDA's Rare Disease Innovation Hub is working to align the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. β’ This alignment aims to resolve a longstanding coordination issue for developers creating treatments for rare diseases.
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