April 11, 2026
FDA PDUFA Dates 2026: The Complete Biotech Catalyst Calendar Guide
What a PDUFA Date Actually Is The Prescription Drug User Fee Act requires the FDA to review New Drug Applications (NDAs) and Biologics License Applications (BLAs) within a set timeframe — typically 10 months for standard review, 6 months for priority review. The PDUFA date is the FDA’s self-imposed deadline to complete that review. It […]
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