A PDUFA date is the target deadline by which the U.S. FDA aims to make a decision on a drug application. PDUFA stands for the Prescription Drug User Fee Act — a 1992 law (renewed every five years) under which drug companies pay fees and, in exchange, the FDA commits to review timelines.
How a PDUFA date is set
When the FDA accepts a New Drug Application (NDA) or Biologics License Application (BLA) for review, it assigns a goal date. Under standard review the goal is ~10 months from filing; under priority review (for drugs that may offer major advances) it's ~6 months. The company usually discloses the date in an 8-K/press release.
What the FDA can decide
ApprovalThe drug can be marketed
Complete Response Letter (CRL)Not approved as submitted — issues to resolve
Date extensionReview period pushed back (e.g., +3 months)
Do PDUFA dates always hold?
No. The FDA can act early, extend the date, or (rarely) miss it. Dates tied to an ongoing trial's primary-completion estimate are softer than an FDA-set goal date — which is why pdufa.bio tags each date's source and confidence.
What happens to the stock?
A PDUFA decision is a binary catalyst. Historically the size of the reaction scales with company size — smaller companies move far more. These are historical base rates, not predictions. See our FDA approvals by year and the live PDUFA calendar.
PDUFA stands for the Prescription Drug User Fee Act, a 1992 U.S. law under which drug makers pay fees and the FDA commits to review-time goals — the 'PDUFA date.'
Is a PDUFA date the same as an approval date?
No. The PDUFA date is the FDA's target to make a decision. The decision can be an approval, a Complete Response Letter (CRL), or a date extension.
How long is FDA review?
About 10 months from filing under standard review and about 6 months under priority review.