On July 30, 2026, the FDA published eleven separate Federal Register notices establishing new user fee rates for Fiscal Year 2027. These updates cover prescription drugs, generic drugs, biosimilars, OTC monograph drugs, medical devices, animal drugs, outsourcing facilities, and certain food-related programs.
Most of these fees take effect October 1, 2026, and stay in place through September 30, 2027. There are two exceptions worth flagging immediately: OMUFA facility fees are split into two installments (October 1, 2026 and February 1, 2027), and the Voluntary Qualified Importer Program (VQIP) fee kicks in earlier, on August 1, 2026.
Why Fees Moved in Different Directions This Year
Before diving into the tables, it helps to understand the mechanism. Most FY2027 rates increased due to the FDA’s standard annual inflation adjustment and shifts in program workload. But a few programs — most notably GDUFA facility fees — actually decreased, because the underlying statutes require the FDA to reduce fees when operating reserves exceed a set threshold (12 weeks of operating costs, in GDUFA’s case). Application fees under the same programs aren’t subject to that same reserve-based correction, which is why you’ll sometimes see one fee category go down while another goes up within the same program.
OMUFA is the clearest example of volatility here: FY2026’s facility fee was a one-time low caused by a statutory reserve correction, and FY2027 fees have rebounded sharply — up 149% — as a direct result.
The Full FY2027 Fee Schedule
All rates effective October 1, 2026 through September 30, 2027, unless otherwise noted. Standard fees shown; small business, waiver, and reduced-fee provisions may apply under each program. Source: Federal Register notices published July 30, 2026 (91 FR 48118–48166).
PDUFA — Prescription Drug
| Fee Category | FY2027 Rate |
|---|---|
| Application requiring clinical data | $4,600,753 |
| Application not requiring clinical data | $2,300,376 |
| Prescription drug program fee | $416,857 |
GDUFA — Generic Drug
| Fee Category | FY2027 Rate |
|---|---|
| ANDA Filing Fee | $375,684 |
| Drug Master File (DMF) | $109,899 |
| API Facility – Domestic | $39,680 |
| API Facility – Foreign | $54,680 |
| FDF Facility – Domestic | $230,033 |
| FDF Facility – Foreign | $245,033 |
| CMO Facility – Domestic | $55,208 |
| CMO Facility – Foreign | $70,208 |
| Applicant Program Fee – Large | $1,927,291 |
| Applicant Program Fee – Medium | $770,916 |
| Applicant Program Fee – Small | $192,729 |
BsUFA — Biosimilar
| Fee Category | FY2027 Rate |
|---|---|
| Initial / annual BPD fee | $10,000 |
| Reactivation fee | $20,000 |
| Application (clinical data required / not required) | $1,124,936 / $562,468 |
| Program fee | $195,887 |
OMUFA — OTC Monograph Drug
| Fee Category | FY2027 Rate |
|---|---|
| MDF facility fee | $47,891 |
| CMO facility fee | $31,927 |
| Tier 1 / Tier 2 OMOR fee | $614,608 / $122,921 |
MDUFA — Medical Device
| Fee Category | FY2027 Rate |
|---|---|
| PMA/PDP/BLA (standard / small business) | $636,732 / $159,183 |
| 510(k) notification (standard / small business) | $28,653 / $7,163 |
| De Novo request (standard / small business) | $191,020 / $47,755 |
| Annual establishment registration | $13,785 |
ADUFA — Animal Drug
| Fee Category | FY2027 Rate |
|---|---|
| Animal drug application | $621,692 |
| Supplemental application | $310,846 |
| Annual product fee | $12,294 |
| Annual establishment fee | $215,520 |
| Annual sponsor fee | $145,476 |
AGDUFA — Animal Generic Drug
| Fee Category | FY2027 Rate |
|---|---|
| Abbreviated application | $132,614 |
| Abbreviated application (512(d)(4)) | $66,307 |
| JINAD file fee | $50,000 |
| Annual product fee | $15,670 |
| Annual sponsor fee (100% / 75% / 50%) | $264,009 / $198,007 / $132,005 |
Outsourcing Facility
| Fee Category | FY2027 Rate |
|---|---|
| Small business establishment fee | $7,142 |
| Non-small business establishment fee | $22,074 |
| Reinspection fee | $21,427 |
FSMA — Reinspection, Recall & Importer Reinspection
| Fee Category | FY2027 Rate |
|---|---|
| Domestic travel | $354/hr |
| Foreign travel | $414/hr |
FSMA — Third-Party Certification
| Fee Category | FY2027 Rate |
|---|---|
| Initial accreditation application | $56,272 |
| Annual accreditation fee | $2,612 |
| Annual certification body fee | $3,266 |
| Direct accreditation application | $56,272 |
| Renewal application | $34,311 |
FSMA — Voluntary Qualified Importer Program (VQIP)
| Fee Category | FY2027 Rate | Effective |
|---|---|---|
| Annual importer participation fee | $9,994 | August 1, 2026 |
The Programs Everyone’s Watching: What Actually Moved
Of all eleven, three tell the most interesting story this cycle:
- GDUFA facility fees dropped despite inflation, because FDA’s operating reserves exceeded the statutory 12-week threshold, triggering a mandatory downward adjustment. GDUFA application fees (ANDA, DMF) were calculated separately and rose instead.
- OMUFA facility fees jumped 149%, rebounding from a one-time statutory low in FY2026. If you manufacture OTC monograph or contract-manufacture OTC monograph products, this is the fee to budget for now.
- PDUFA fees declined for the second straight year — a comparatively quiet cycle for prescription drug applicants.
The other eight programs — BsUFA, MDUFA, ADUFA, AGDUFA, Outsourcing Facility, and the three FSMA fees — saw more typical inflation-driven adjustments, without the dramatic swings.
Why This Matters Beyond the Numbers
Eleven notices published on the same day, covering everything from a $9,994 importer fee to a $4.6 million drug application fee, is a lot to track — especially when a few of them move in opposite directions from what you might expect. The practical risk isn’t usually the rate itself; it’s missing a deadline or a program-specific quirk (like OMUFA’s installment schedule or VQIP’s early effective date) buried in a Federal Register notice you never had reason to read closely.
What to Do Before October 1
- Confirm which FY2027 fee schedule applies to any application, facility registration, or program fee due on or after October 1, 2026 — don’t assume last year’s invoice amount carries forward.
- Budget for OMUFA’s two-installment structure: 50% due October 1, 2026, and 50% due February 1, 2027. This split-payment option is a one-time transition measure for FY2027 only; from FY2028 onward, full payment will be due October 1.
- VQIP participants: your annual fee is due before October 1 to maintain FY2027 program benefits, and it’s non-refundable — don’t wait until the deadline week.
- Medical device establishments: renew small business qualification, if applicable, before September 30, 2026, to lock in reduced MDUFA fees.
- Third-party certification program participants: budget for the updated application, annual, and renewal fees shown above.
- Animal drug and animal generic drug sponsors: check both your application-stage and annual sponsor/establishment fees — ADUFA and AGDUFA each carry several fee categories that can apply simultaneously.
Why Your U.S. Agent Matters More Than Usual This Cycle
If you’re a foreign facility, your U.S. Agent isn’t just a mailbox — this fee cycle is exactly when that role earns its keep. FDA doesn’t always send fee notices, invoices, or reinspection triggers directly to the facility overseas; a lot of that correspondence lands with the designated U.S. Agent first, and it’s on them to flag it, translate the deadline into something actionable, and make sure it doesn’t sit unread in an inbox nobody’s checking on U.S. time. With OMUFA’s 149% jump and its new split-payment structure, GDUFA’s mixed facility-versus-application movement, and VQIP’s earlier August 1 effective date all landing in the same cycle, a disengaged or slow-to-respond U.S. Agent is how a foreign facility ends up finding out about a fee increase after the payment deadline has already passed — not before. If your current U.S. Agent arrangement feels more like a formality than an active point of contact, this is a good year to double-check that they’re actually watching your account, not just holding the title.
Plan Your FDA FY2027 Requirements With Confidence
FDA FY2027 user fees are more than just updated numbers. For drug manufacturers, generic drug companies and DMF holders, the correct fee category, payment requirement and submission process can directly affect regulatory planning.
Foreign pharmaceutical companies should also review their FDA registration, drug listing and U.S. Agent arrangements to ensure their U.S. regulatory responsibilities are properly managed.
👉 Need help with FDA U.S. Agent services, DMF submissions or drug regulatory requirements?
🚀FDA Pals can help you navigate the applicable FDA requirements and prepare for FY2027.
Frequently Ask Questions
Q. 1) Do these fee increases just… apply automatically, or do I need to do something on my end?
Ans: They apply automatically — you won’t get an email asking you to “opt in” to the new rate. The moment your application, facility, or program fee comes due on or after October 1, 2026, it’s billed at the FY2027 rate, full stop. What actually takes effort on your end is figuring out which fee category applies to you, because several of these programs (GDUFA and MDUFA especially) have four or five different fee types that all move by different percentages. That’s the part worth double-checking before you assume you know what’s coming.
Q. 2) Why did some fees go down this year when literally everything else in life is getting more expensive?
Ans: Fair question, and it trips a lot of people up. Most FDA fees do follow standard inflation, so a rise is the default expectation. But a few programs — GDUFA facility fees being the textbook example — have a legal requirement baked into their statute: if FDA’s operating reserves grow past a certain size (12 weeks’ worth of costs, in GDUFA’s case), the agency is required to hand some of that back by lowering next year’s fees. It’s not a discount FDA chose to give you; it’s a rule Congress wrote into the program. So when you see one fee category drop while a related one rises in the same program, that’s usually why.
Q. 3) Is the OMUFA two-payment option a permanent thing now, or just this year?
Ans: Just this year. Think of it as a one-time transition perk. OMUFA’s payment deadline used to fall in June; starting FY2027, it’s moving to October 1 to line up with GDUFA and PDUFA. Since that’s a real shift for anyone budgeting around the old June date, FDA is letting facilities split the FY2027 bill into two 50% payments — one on October 1, 2026, and the other on February 1, 2027 — as a cushion. From FY2028 on, expect the full amount due in one shot on October 1, so don’t build the installment habit into your long-term planning.
Q. 4) I only deal with food, not drugs or devices — does any of this actually touch my business?
Ans: Mostly no, and that’s worth saying plainly since it’s easy to see “FDA fees” and assume the worst. Routine food facility registration — the thing most food businesses actually deal with — still has zero FDA fee attached to it, and nothing in this update changes that. The FSMA-related items in this list (Reinspection/Recall, Third-Party Certification, VQIP) are narrow, situational programs. You’d only encounter them if FDA had to reinspect your facility after a violation, if you’re part of the accredited third-party certification system, or if you’ve voluntarily enrolled in the Voluntary Qualified Importer Program for faster import clearance. If none of those describe you, this update is background noise, not a bill.
Q. 5) My facility qualifies as a “small business” — do these rates even apply to me?
Ans: Not at the full rate, in most cases. Several programs on this list — MDUFA and Outsourcing Facility fees, for example — publish separate, meaningfully lower rates for qualified small businesses. The catch is that “qualified” isn’t automatic; you typically have to apply for and maintain that status with FDA, and for MDUFA specifically, that qualification needs to be current before September 30, 2026, to lock in the reduced FY2027 tier. If you’ve let your small business certification lapse without realizing it, you could get billed at the standard rate without any warning.
Q. 6) What actually happens if I just… don’t pay on time?
Ans: Nothing good, and the consequences vary by program but trend in the same direction: delayed reviews, holds on applications, or in the case of registration-linked fees, a facility that’s effectively out of compliance until the balance is settled. FDA doesn’t typically chase down late payments quietly — a missed user fee can stall an application that was otherwise ready to move forward, which is a frustrating way to lose months over what’s ultimately an accounting oversight rather than a scientific or regulatory one.
Q. 7) This is a lot of programs and a lot of numbers — how do I even know which ones apply to me?
Ans: Start with what you actually do: if you file drug applications, you’re likely looking at PDUFA, GDUFA, or BsUFA depending on the product type. If you make devices, it’s MDUFA. Animal health products point you to ADUFA or AGDUFA. Compounding pharmacies fall under Outsourcing Facility fees. And food businesses generally sit outside all of this unless they’re specifically enrolled in VQIP or third-party certification. If you’re still not sure after that, it’s genuinely faster to ask someone who deals with these programs daily than to reverse-engineer it from eleven separate Federal Register notices.
🚀Reach out to FDA Pals — we’ll help you map out exactly what applies to you and when it’s due.👉 Questions about how the FY2027 fee changes affect your applications, facilities, or registrations?
