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PDUFA Date

PDUFA

FDA & Regulatory

The Prescription Drug User Fee Act (PDUFA) date is the deadline by which the FDA aims to complete its review of a new drug application and issue a decision. It is one of the most-watched binary catalysts in biotech investing, since the outcome (approval or Complete Response Letter) can move a stock sharply.

Related terms

Complete Response LetterPriority ReviewNew Drug ApplicationBiologics License ApplicationAdvisory Committee Meeting

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