Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
Of the 31 2026 FDA decisions in this archive whose outcome and dates we have checked against a primary source, 20 came before the PDUFA goal date, 10 landed on it, and 1 came after. The median decision landed 2 days before the goal date.
What is counted: 2026 decisions where this archive holds the PDUFA goal date, the actual FDA action date, and a primary source we link on the decision page. Decisions inferred from share-price behaviour are excluded. We do not compute a rate across earlier years: our coverage of them is far thinner, so such a number would describe our own collection rather than the FDA's behaviour.
Left out because a date has no document behind it
6 2026 decisions with a sourced outcome are not counted above: LLY (no sponsor filing states a goal date); LNTH (the date held is the sponsor's announcement day; the filing does not state the day the FDA acted); MRK (no sponsor filing states a goal date); NVS (no sponsor filing states a goal date); OTSKY (no sponsor filing states a goal date); RHHBY (no sponsor filing states a goal date). A margin is the difference of two dates, and both have to come from a document that states them. These rows keep their approval and their decision page; they re-enter the statistic if the missing date is documented.
Questions
Does the FDA always decide on the PDUFA date?
No. In this archive's 2026 sourced decisions, 20 of 31 came before the PDUFA goal date, 10 on it and 1 after. The goal date is the date by which the FDA aims to complete its review, not a fixed announcement date.
Can the FDA approve a drug early?
Yes. The PDUFA date is a target for completing the review, so the agency can act sooner, and in this archive several 2026 decisions did: the earliest by 110 days. It can also extend the date, usually when the company submits a major amendment that needs more review time.
Which decisions does this page count?
Only 2026 decisions where this archive holds the PDUFA goal date, the actual action date, and a primary source (FDA notice, SEC filing or company release) that we link. Decisions inferred from share-price behaviour are excluded, and no rate is computed across earlier years because our coverage of them is much thinner and a rate would measure our collection rather than the FDA.
Historical record of specific decisions, each linked to its source. Not a prediction about any pending application, and not investment advice.