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.
A PDUFA date is the FDA's target deadline for deciding on a drug application, set under the Prescription Drug User Fee Act. Standard reviews carry a roughly ten-month goal, priority reviews about six. On that date the FDA can approve the drug, issue a Complete Response Letter, or extend the review, commonly by three months. In practice the date is a goal, not a promise: of the 31 sourced 2026 decisions in our decision-timing study, 20 came before the goal date, 9 landed on it and 2 came after it.
A PDUFA date is the date by which the FDA has committed to complete its review of a drug application and issue a decision. It is a goal date, not a deadline in law and not an approval date. The agency can act before it, can extend it, and on the date itself can say no as easily as yes. Nothing about a PDUFA date implies an outcome.
Before 1992 the FDA had no funded commitment to review drug applications within a set time, and reviews could run for years. The Prescription Drug User Fee Act, enacted in 1992 and reauthorised by Congress roughly every five years since, set up a trade: drug companies pay user fees, and in exchange the FDA commits to performance goals for how quickly it completes reviews. A PDUFA date is one of those goals, applied to a single application. The money funds reviewer capacity; the goal dates are what the public gets back for it.
When a company submits a New Drug Application (NDA) or Biologics License Application (BLA), the FDA first decides whether to file it for review, which takes about 60 days. The goal clock for a new molecular entity runs from that filing date, not from the day the company submitted. From filing, the goal is about ten months under standard review and about six months under priority review, which is granted when a drug may offer a significant improvement over available options. If the company sends substantial new information late in the cycle, the FDA can treat it as a major amendment and extend the goal date, usually by three months. Companies normally disclose the date in a press release or an SEC filing, which is where the dates on this site come from.
A Complete Response Letter is not a rejection of the drug forever: companies frequently resubmit, and a resubmission starts a new review clock of its own, two or six months depending on what changed. More on Complete Response Letters.
It is the day the answer becomes public. For patients and clinicians waiting on a treatment, the PDUFA date is when they find out whether it will be available; for the company it is the date around which manufacturing, launch and staffing are planned. It is also the only scheduled point in a long private process: almost everything else about an FDA review happens out of view, and the goal date is the one part of the calendar that is announced in advance.
Because it is a goal rather than a guarantee, the useful question is how often it holds. We publish that from our own sourced archive rather than asserting it: see does the FDA decide on the PDUFA date?, which counts every 2026 decision where we hold both the goal date and the actual action date with a primary source for each. This site publishes dates, sources and historical statistics; it does not publish approval odds, and nothing here is investment advice.
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