Usage Examples
- Our PDUFA date is 12 March, so commercial is building launch supply against a first-cycle approval.
- Finance needs the FY 2026 PDUFA application fee in the Q1 forecast before we ship the NDA.
- That is a PDUFA goal, not a statutory deadline, so a major amendment can move it.
What is PDUFA (Prescription Drug User Fee Act)?
PDUFA is the US statute authorizing FDA to collect user fees from human drug and biologic sponsors, tying that revenue to negotiated review performance goals that produce the target action date known as the PDUFA date.
PDUFA exists because Congress decided that industry, not appropriations alone, should fund the reviewers who evaluate its applications. Sections 735 and 736 of the FD&C Act let FDA collect fees from sponsors of human drug and biologic applications, and each reauthorization, currently the Prescription Drug User Fee Amendments of 2022 (PDUFA VII), trades that revenue for review performance goals FDA negotiates with industry.
PDUFA covers the innovator side of FDA's drug program: an application fee on each human drug or biologic application, $4,682,003 in FY 2026, or $2,341,002 where the application requires no clinical data, plus a prescription drug program fee of $442,213. PDUFA does not cover generics, biosimilars, or devices, which run on GDUFA, BsUFA, and MDUFA, and it buys review capacity, not a lower approval standard.
PDUFA reaches most teams as a single date on a slide. FDA decides within 60 days of receiving an NDA whether it may be filed, and the filing date is then fixed at 60 days after receipt, so every downstream milestone counts from filing rather than from the day the submission left your hands. Regulatory, supply, and investor plans all hang off that arithmetic.
Not to be confused with
- The PDUFA date and the approval date
- the PDUFA date is when FDA aims to act. The action can be a complete response letter under 21 CFR 314.110, so the date promises a decision, never a favourable one.
- 21 CFR 314.100
- 314.100 sets the regulatory 180-day initial review cycle. The PDUFA date is a negotiated performance goal from the goals letter, so missing it is a performance miss against a commitment, not a violation of a regulation.
- GDUFA, BsUFA and MDUFA
- parallel user fee programs for generics, biosimilars and devices, each with its own fee schedule and goal structure. A PDUFA rate never applies to an ANDA or a 510(k).
- Priority Review
- a review designation that changes which goal length FDA works to. It does not change the application fee, which is set by whether the application requires clinical data.
PDUFA obligations divide into what you pay and what the payment buys.
What you must do
- 1Pay the FY 2026 application fee of $4,682,003, or $2,341,002 where the application does not require clinical data, for applications in the 1 October 2025 to 30 September 2026 fee period90 FR 35866
- 2Budget the FY 2026 prescription drug program fee of $442,213 as a recurring cost of holding an approved product, separate from the one-time application fee90 FR 35866
- 3Confirm the fee category against the current-year notice before submitting, since the rates derive from sections 735 and 736 of the FD&C Act and are re-announced every fiscal yearFD&C Act sections 735 and 736 (21 U.S.C. 379g and 379h)
- 4Submit an application complete enough to be filed, because FDA determines within 60 days after receiving an NDA whether the NDA may be filed at all21 CFR 314.101(a)(1)
- 5Count every review milestone from the filing date, fixed at 60 days after the date FDA received the NDA, not from the submission date21 CFR 314.101(a)(2)
- 6Plan for FDA to issue either an approval letter or a complete response letter within the initial review cycle of 180 days21 CFR 314.100
Common mistakes
Treating the PDUFA date as an approval date
FDA's action on the goal date can be a complete response letter under 21 CFR 314.110. Launch supply builds, sales hiring, and investor guidance keyed to the date as an approval are pricing in an outcome the date never promised.
Counting the clock from the day you shipped the submission
the clock runs from the filing date, which is fixed at 60 days after FDA receives the NDA. Teams that count from the courier receipt brief a date two months earlier than the one FDA is working to, then explain the gap to a board that already wrote it down.
Budgeting a prior year's fee rate
the rates are reset every fiscal year by Federal Register notice and apply only to the 1 October to 30 September window. A submission budget carrying last year's number is out of date the moment the new notice publishes, and the correction lands on the quarter you submit in.
When This Matters
- Our PDUFA date is 12 March, so commercial is building launch supply against a first-cycle approval.
- Finance needs the FY 2026 PDUFA application fee in the Q1 forecast before we ship the NDA.
- That is a PDUFA goal, not a statutory deadline, so a major amendment can move it.
Frequently Asked Questions
A PDUFA date is FDA's target date for acting on a drug or biologic application, set by the performance goals PDUFA fees pay for. It is a negotiated commitment, not a statutory deadline, and the action taken on it can be a complete response letter rather than an approval.
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