What a PDUFA date is, and why the FDA doesn't publish them

A PDUFA date is the day by which the US Food and Drug Administration has committed to finish reviewing a drug or biologic application and give the company its answer. It is the single most-watched date in biotech, and the FDA never announces it. Everything you know about a PDUFA date comes from the company that received it.

Where the name comes from

PDUFA is the Prescription Drug User Fee Act, first passed in 1992. Before it, drug reviews could drag on for years because the FDA lacked the staff to work through them. The deal PDUFA struck was simple: companies pay a fee with each application, and in return the FDA commits to review timelines it publishes in advance and reports against.

The Act has to be renewed by Congress every five years, and each renewal comes with a new "commitment letter" setting out the goals. The current version, PDUFA VII, runs to 30 September 2027. The FDA published the proposed PDUFA VIII commitments in August 2026 for fiscal years 2028 to 2032, and Congress has to pass them before the current authority lapses.

The "PDUFA date" is the review goal for one specific application. In filings it is usually called the PDUFA target action date, or the goal date.

How the date is set

The clock starts when the company submits a New Drug Application (NDA) or a Biologics License Application (BLA). The difference between the two matters less here than you might think, because both get the same review goals.

Filing review (60 days). The FDA first decides whether the application is complete enough to review at all. If it isn't, the agency can refuse to file it, and the company has to fix and resubmit.
Acceptance and the date. If the application is filed, the FDA tells the company its review designation and goal date. Under PDUFA VII the agency also aims to send a "Day 74 letter" listing any problems it has spotted during that first look.
The review clock. For a new molecular entity or an original biologic, the goal is 10 months from the 60-day filing date for a standard review, or 6 months for a priority review. That works out at roughly 12 months or 8 months from submission. For other applications, such as a new formulation of an approved drug or a new use for one, the 10- and 6-month clocks run from the day the FDA received it.

From the tracker

PolyPid's 6-K of 29 July 2026 reported that the FDA "did not identify any filing review issues and set a PDUFA target action date of November 28, 2026" for D-PLEX100. That wording is the Day 74 letter, relayed by the company. See the PolyPid page.

Why the FDA doesn't publish the date

The FDA treats a pending application as confidential. Its own regulation for drugs, 21 CFR 314.430, says the agency will not publicly disclose that an application even exists before it sends an approval letter, unless the company has already made that public. The matching rule for biologics is 21 CFR 601.51. So there is no official calendar to look up, and there never has been.

The dates become public because companies choose to disclose them. No rule requires a company to announce its PDUFA date, but for a small biotech with one or two products, the date the FDA will rule on its lead drug is about as material as information gets. Most companies announce it in a press release and file that release with the SEC as an exhibit to a Form 8-K (or a 6-K for foreign companies). That filing is what every row in our tracker links to, and our guide to checking a date on EDGAR shows you how to find it yourself.

This is also why the date sometimes shows up later than you'd expect, or only in the middle of a quarterly results release, and why catalyst calendars sometimes disagree: some copy from each other rather than from the filing.

A goal, not a deadline

The PDUFA date is the date the FDA aims to act by. Several things can move it.

The FDA can act early

Early approvals happen more often than people assume, and they're unannounced: the first anyone hears is the company's press release.

From the tracker

Nuvalent's zidesamtinib had a PDUFA date of 18 September 2026 and was approved on 22 July, almost two months early (FDA notice). Ionis's zilganersen was approved 19 days ahead of its 22 September date. Vera Therapeutics' atacicept was approved on the PDUFA date itself. All three sit in the decided archive on the tracker.

A major amendment can push it back three months

If the company submits a substantial amount of new information while the review is under way, the FDA can classify it as a major amendment and extend the goal date by three months. An extension is not a rejection, but it does tell you the review raised questions significant enough to need more data.

From the tracker

Capricor's 8-K of 24 August 2026 reported that the FDA "extended the PDUFA target action date ... from August 22, 2026 to November 22, 2026" after classifying a BLA amendment as a major submission. Praxis reported a similar extension for relutrigine. The tracker labels these rows PDUFA date (extended).

The FDA can miss it

The commitment is to meet the goal for the large majority of applications, not every one. Inspections of manufacturing sites, staffing, or a late-arriving issue can delay an action past the date. When that happens you'll usually hear it from the company, often days later.

Weekends

Because the goal date is a calendar calculation, it often lands on a Saturday or Sunday. The FDA generally acts by the last working day before it, so a Sunday PDUFA date often means a Friday announcement.

What happens on the day

By the goal date the FDA sends one of two letters. An approval letter means the product can be marketed in the US for the approved use, with the approved label. A Complete Response Letter means the FDA won't approve the application in its current form and explains why. There is no third "maybe" letter, although an approval can come with a narrower label, a boxed warning, or post-marketing requirements that change what the approval is worth.

Some applications also go before an FDA advisory committee weeks or months before the PDUFA date. That meeting is public and announced in advance, and it often tells you more about the FDA's concerns than anything else before the decision.

How to use PDUFA dates sensibly

Check the source. A PDUFA date that appears on a calendar without a company filing behind it may be a guess, a typo or a different indication. Our rows say Reported until someone has read the company's own document.
Look for later filings. Dates move. The most recent 8-K, 6-K or quarterly report is the one that counts.
Know which application it is. A company can have several PDUFA dates at once for the same drug in different conditions. Cogent Biosciences, for example, has separate dates for bezuclastinib in GIST and in systemic mastocytosis (Cogent page).
Don't read the date as a prediction. A date tells you when the decision is due, not what it will be.

More guides

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