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PDUFA date

The date by which the FDA aims to decide on a drug application.

FundamentalsIntermediate

Definition

Under the Prescription Drug User Fee Act, the FDA sets a target action date for each new drug application. For small biotech companies, the decision is a major event for the stock.

Watch out for

Outcomes can be binary and moves can be large in either direction. The FDA can also extend or miss a target date.

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