Term
PDUFA date
The FDA's target date for deciding a drug application, set under the Prescription Drug User Fee Act.
When the FDA accepts a marketing application, it assigns a goal date for its decision under the Prescription Drug User Fee Act (PDUFA). A standard review targets a decision roughly ten months from acceptance; a priority review targets roughly six.
The date is a goal, not a guarantee. The agency can approve early, ask for more information, extend the clock after a major amendment, or issue a complete response letter instead of an approval. Investors watch PDUFA dates because an approval decision is one of the few scheduled events that can settle a drug's commercial question on a known day.
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