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FDA & Regulatory

PDUFA Date

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.

Category
FDA & Regulatory
Abbreviation
PDUFA
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Prepared research question

How does PDUFA Date affect the view of a biotech company in practice?

Run cited research

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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

Learn more

PDUFA Dates calendar — Track PDUFA action dates for biotech and pharma companies. Free FDA decision calendar with tickers, drug names, and outcomes. Source dates and context shown.What Is PDUFA? A Complete Guide for Biotech Investors

From term to thesis rule

Investigate how PDUFA Date changes a biotech thesis

Define when PDUFA Date should count, block, or trigger a deeper check; BioSniper will compile that logic against available evidence.

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