PDUFA Dates

PDUFA (Prescription Drug User Fee Act) dates are the deadlines by which the FDA must complete its review of drug applications. These are the most-watched catalysts in biotech investing, often causing 50-200% stock price moves.

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What Is PDUFA? A Complete Guide for Biotech Investors

Understand PDUFA dates, how the FDA review process works, and why PDUFA action dates are the most important catalysts in biotech investing.

FDA Complete Response Letters (CRLs): What They Mean for Biotech Investors

Learn what a Complete Response Letter is, why the FDA issues CRLs, how companies respond, and what CRL outcomes mean for biotech stock prices and timelines.

FDA Priority Review vs. Standard Review: What the Difference Means for Biotech Investors

Compare FDA Priority Review and Standard Review timelines, learn what triggers each designation, and understand how review type affects drug approval probability and stock prices.