FDA User Fee Programs: PDUFA, GDUFA, BSUFA, and MDUFA Explained
FDA operates four major user fee programs that support review of drugs, generics, biosimilars, and medical devices. PDUFA covers NDA and BLA review, GDUFA covers ANDAs and related generic-drug fees, BsUFA covers biosimilar development and 351(k) application fees, and MDUFA covers device submissions such as PMAs, 510(k)s, and De Novo requests. Each program has its own statutory fee structure, annual fee notices, and five-year reauthorization cycle.
Key Takeaways
Key Takeaways
- PDUFA VII, GDUFA III, BsUFA III, and MDUFA V are the current user fee authorities and run through September 30, 2027.
- FY 2026 fee amounts differ substantially by program and are published on FDA's official fee pages each fiscal year.
- Some programs offer fee waivers, refunds, or reduced fees, but eligibility rules differ by statute.
- User fee structure is not uniform across programs: PDUFA and BsUFA use program fees, GDUFA uses program and facility fees, and MDUFA uses submission and establishment fees.
- FDA user fee programs are the legislative framework through which the pharmaceutical, generic drug, biosimilar, and medical device industries pay fees to FDA in exchange for defined review performance goals. This system, first established in 1992 with PDUFA, is now a central part of how FDA funds and manages regulated-product review programs.
- Each user fee program must be reauthorized by Congress every five years through a process that includes negotiations, public meetings, and legislation.
- In this guide, you will learn:
- The history and evolution of each FDA user fee program
- Fee types and current amounts for each program
- Performance goals and how they are measured
- The reauthorization process and its implications
- How user fees affect review timelines and FDA operations
- Related guides:
- PDUFA dates 2026
- FDA standard review vs priority review
- GDUFA user fees guide
- Drug Master File guide
- 510(k) vs De Novo guide
- 505(b)(2) vs ANDA
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Overview of FDA User Fee Programs
The Four Major Programs
| Program | Full Name | Enacted | Current Authorization | Products Covered |
|---|---|---|---|---|
| PDUFA | Prescription Drug User Fee Act | 1992 | PDUFA VII (FY 2023-2027) | NDA/BLA (brand drugs, biologics) |
| GDUFA | Generic Drug User Fee Amendments | 2012 | GDUFA III (FY 2023-2027) | ANDA (generic drugs) |
| BSUFA | Biosimilar User Fee Act | 2012 | BSUFA III (FY 2023-2027) | Biosimilar BLAs (351(k)) |
| MDUFA | Medical Device User Fee Amendments | 2002 | MDUFA V (FY 2023-2027) | PMA, 510(k), De Novo devices |
FDA Funding Model
FDA user fee programs supplement annual appropriations. The exact balance between appropriated funds and user fee funding varies by program and fiscal year.
PDUFA: Prescription Drug User Fee Act
History and Evolution
PDUFA is the foundational modern user fee program for human drugs and biologics.
| Authorization | Period | Key Developments |
|---|---|---|
| PDUFA I | FY 1993-1997 | Established user fees; set first review timeline goals |
| PDUFA II | FY 1998-2002 | Strengthened performance goals; added meeting management |
| PDUFA III | FY 2003-2007 | Risk management focus; added post-market safety commitments |
| PDUFA IV | FY 2008-2012 | Enhanced safety monitoring; structured benefit-risk framework |
| PDUFA V | FY 2013-2017 | Patient-focused drug development; regulatory science |
| PDUFA VI | FY 2018-2022 | Real-world evidence; complex clinical trials; RTOR pilot |
| PDUFA VII | FY 2023-2027 | Enhanced communication; rare disease focus; digital health |
PDUFA Fee Types
PDUFA collects three FY 2026 fee types under Section 736(a) of the FD&C Act:
| Fee Type | Who Pays | When | FY 2026 Amount |
|---|---|---|---|
| Application fee | Sponsor submitting NDA/BLA | At submission | $4,682,003 (with clinical data) |
| Application fee (no clinical data) | Sponsor submitting NDA/BLA | At submission | $2,341,002 |
| Program fee | Qualifying approved prescription drug products | Annually | $442,213 |
“Note: Fee amounts are adjusted annually and published in FDA's fee notices. Waivers and exemptions are set by statute and do not apply uniformly across all fee categories.
PDUFA VII Performance Goals
| Application Type | Review Classification | Timeline | Target |
|---|---|---|---|
| Original NDA/BLA | Standard | 10 months from filing | 90% on time |
| Original NDA/BLA | Priority | 6 months from filing | 90% on time |
| Class 1 resubmission | N/A | 2 months | 90% on time |
| Class 2 resubmission | N/A | 6 months | 90% on time |
| Manufacturing supplement (prior approval) | N/A | 4 months | 90% on time |
| Type A meeting | N/A | Schedule within 30 days of request | 90% on time |
| Type B meeting | N/A | Schedule within 60 days of request | 90% on time |
| Type C meeting | N/A | Schedule within 75 days of request | 90% on time |
PDUFA VII Special Initiatives
PDUFA VII introduced several new commitments beyond standard review timelines:
Real-Time Oncology Review (RTOR): Continuation and expansion of the pilot program allowing FDA to begin review of efficacy data before the complete NDA/BLA is submitted, potentially shortening oncology drug review.
Patient-Focused Drug Development: FDA committed to developing guidance on incorporating patient experience data into regulatory decision-making, building on the PDUFA V and VI framework.
Rare Disease Review Enhancement: Additional resources and specialized review teams for rare disease applications, including expanded use of natural history data and flexible trial designs.
Digital Health Technologies: Framework for evaluating digital health technologies as tools for drug development, including digital biomarkers and decentralized clinical trial endpoints.
GDUFA: Generic Drug User Fee Amendments
Background
GDUFA established the modern user fee framework for generic drugs.
GDUFA History
| Authorization | Period | Key Developments |
|---|---|---|
| GDUFA I | FY 2013-2017 | Established generic drug fees; set ANDA review goals |
| GDUFA II | FY 2018-2022 | Pre-ANDA meetings; enhanced review communications |
| GDUFA III | FY 2023-2027 | Complex generics; improved communication; site inspection goals |
GDUFA Fee Types
GDUFA collects fees under Section 744A of the FD&C Act:
| Fee Type | Who Pays | FY 2026 Amount |
|---|---|---|
| ANDA application fee | Each ANDA submission | $358,247 |
| Drug Master File (DMF) fee | DMF holder (initial filing) | $102,584 |
| Generic drug program fee (large) | Large-size business | $1,918,377 |
| Generic drug program fee (medium) | Medium-size business | $767,351 |
| Generic drug program fee (small) | Small-size business | $191,838 |
| Domestic API facility fee | Domestic API facility | $43,549 |
| Foreign API facility fee | Foreign API facility | $58,549 |
| Domestic FDF facility fee | Domestic finished dosage form facility | $238,943 |
| Foreign FDF facility fee | Foreign finished dosage form facility | $253,943 |
| Domestic CMO facility fee | Domestic contract manufacturing organization | $57,346 |
| Foreign CMO facility fee | Foreign contract manufacturing organization | $72,346 |
GDUFA III Performance Goals
| Activity | Timeline Goal | Target |
|---|---|---|
| Standard ANDA review (original) | 10 months from submission | 90% on time |
| Priority ANDA review | 8 months from submission | 90% on time |
| ANDA amendment review | 3 months | 90% on time |
| Pre-ANDA meeting | Respond within 120 days | 90% on time |
| Complete Response (ANDA) | 10 months from receipt of response | 90% on time |
| Controlled correspondence | Respond within 120 days | 90% on time |
GDUFA Program Structure
GDUFA combines application fees, program fees, and facility fees. Sponsors should confirm which fee categories apply to their business model and manufacturing footprint.
BSUFA: Biosimilar User Fee Act
Background
BSUFA was enacted alongside GDUFA in 2012 as part of the FDA Safety and Innovation Act (FDASIA). It provides funding for FDA review of biosimilar biological products submitted under the abbreviated pathway established by the Biologics Price Competition and Innovation Act (BPCIA) of 2010.
BSUFA History
| Authorization | Period | Key Developments |
|---|---|---|
| BSUFA I | FY 2013-2017 | Established biosimilar fees; initial review framework |
| BSUFA II | FY 2018-2022 | Enhanced review; interchangeability guidance |
| BSUFA III | FY 2023-2027 | Improved pre-submission interactions; streamlined review |
BSUFA Fee Types
BSUFA collects fees under Section 744H of the FD&C Act:
| Fee Type | Who Pays | FY 2026 Amount |
|---|---|---|
| Initial BPD fee | Sponsor entering the BPD program | $10,000 |
| Annual BPD fee | Sponsor in the BPD program | $10,000 |
| Reactivation fee | Sponsor resuming BPD participation | $20,000 |
| Application fee (clinical data required) | 351(k) application | $1,200,794 |
| Application fee (clinical data not required) | 351(k) application | $600,397 |
| Program fee | Eligible approved biosimilar biological product | $209,097 |
BSUFA III Performance Goals
| Activity | Timeline Goal | Target |
|---|---|---|
| Original 351(k) BLA review | 10 months from filing (standard) | 90% on time |
| Priority 351(k) BLA review | 6 months from filing | 90% on time |
| Resubmission review | 6 months (Class 2) | 90% on time |
| Pre-submission meeting | Schedule within 75 days | 90% on time |
| Mid-cycle communication | During review | Per commitment letter |
BsUFA Program Structure
BsUFA is structured around the biosimilar biological product development program, application fees, and an annual program fee for eligible approved biosimilar products.
MDUFA: Medical Device User Fee Amendments
Background
MDUFA, first enacted in 2002 as part of the Medical Device User Fee and Modernization Act (MDUFMA), funds FDA review of premarket applications for medical devices. While this program covers devices rather than drugs, understanding MDUFA is relevant for combination products and the broader FDA user fee framework.
MDUFA History
| Authorization | Period | Key Developments |
|---|---|---|
| MDUFA I | FY 2003-2007 | Established device fees; initial review goals |
| MDUFA II | FY 2008-2012 | Improved predictability; established review clock |
| MDUFA III | FY 2013-2017 | Shared outcome goals; total time to decision |
| MDUFA IV | FY 2018-2022 | Patient engagement; benefit-risk framework |
| MDUFA V | FY 2023-2027 | Digital health; real-world evidence for devices |
MDUFA Fee Types
| Fee Type | Application Category | FY 2026 Amount |
|---|---|---|
| PMA application fee | Premarket Approval Application | $579,272 |
| 510(k) notification fee | Premarket Notification | $26,067 |
| De Novo classification fee | De Novo request | $173,782 |
| PMA panel-track supplement | Major PMA change | $463,418 |
| Establishment registration fee | Registered device establishments | $11,423 |
MDUFA V Performance Goals
| Submission Type | FDA Decision Timeline | Target |
|---|---|---|
| PMA | 180 FDA days | 90% on time |
| 510(k) | 90 FDA days | 95% on time |
| De Novo | 150 FDA days | 90% on time |
| Panel-track supplement | 180 FDA days | 90% on time |
“Note for Drug-Device Combinations: Products that are drug-device combinations (e.g., pre-filled syringes, autoinjectors, combination products) may involve both PDUFA and MDUFA fee considerations. The primary mode of action determines the lead review center (CDER, CBER, or CDRH) under 21 CFR Part 3.
Cross-Program Comparison
Fee Comparison by Program
| Program | Example FY 2026 Application Fee | Recurring Fee Structure |
|---|---|---|
| PDUFA | $4,682,003 (application requiring clinical data) | Annual program fee |
| GDUFA | $358,247 (ANDA) | Program fees and facility fees |
| BsUFA | $1,200,794 (351(k) with clinical data required) | BPD fees and annual program fee |
| MDUFA | $579,272 (PMA) | Establishment registration fee |
Timeline Comparison
| Program | Standard Review Goal | Priority/Expedited Goal |
|---|---|---|
| PDUFA | 10 months from filing | 6 months from filing |
| GDUFA | 10 months from submission | 8 months from submission |
| BSUFA | 10 months from filing | 6 months from filing |
| MDUFA | 180 FDA days (PMA) | N/A |
The Reauthorization Process
How Reauthorization Works
Each user fee program must be reauthorized by Congress every five years. The process follows a defined sequence:
| Phase | Timing (Before Expiration) | Activities |
|---|---|---|
| Preliminary discussions | 30-36 months | FDA begins internal assessment of current program |
| Public meetings | 24-30 months | FDA holds public meetings to gather stakeholder input |
| Negotiations | 18-24 months | FDA and industry negotiate commitment letter terms |
| Commitment letter finalized | 12-18 months | FDA and industry agree on performance goals |
| Congressional review | 6-12 months | Legislation drafted, committee hearings held |
| Congressional vote | 0-6 months | Senate and House vote on reauthorization |
| President signs | Before October 1 | Law enacted before program expiration |
What Happens Without Reauthorization
If Congress does not reauthorize a user fee program before it expires, FDA's authority to assess and collect those fees lapses. Sponsors should monitor the statutory reauthorization cycle because these programs currently run through September 30, 2027.
PDUFA VIII and Beyond
The current authorizations (PDUFA VII, GDUFA III, BsUFA III, MDUFA V) expire on September 30, 2027.
Fee Waivers and Reductions
PDUFA Fee Waivers
Section 736(d) of the FD&C Act provides for fee waivers in specific circumstances:
| Waiver Type | Eligibility | Effect |
|---|---|---|
| Small business waiver | First NDA/BLA; <500 employees; no approved product | Application fee waived for first application |
| Barrier to innovation | Fee presents significant barrier | Partial or full waiver |
| Public health emergency | Drug addresses declared emergency | Full waiver |
| Orphan drug | Application solely for rare disease (Section 526) | Application fee waived |
GDUFA Fee Waivers
| Waiver Type | Eligibility |
|---|---|
| First ANDA | Small applicant's first ANDA |
| Prior Approval Supplement (PAS) | Certain PAS submissions |
FDA charges user fees under statutes enacted by Congress to support defined review activities and performance programs. The exact share of FDA funding attributable to user fees varies by program and fiscal year.
Key Regulatory References
| Reference | Citation |
|---|---|
| PDUFA (original) | Pub. L. 102-571, October 29, 1992 |
| PDUFA VII Reauthorization | FDORA, Pub. L. 117-328, December 29, 2022 |
| PDUFA Fee Authority | FD&C Act Sections 735-736 |
| GDUFA Fee Authority | FD&C Act Sections 744A-744C |
| BSUFA Fee Authority | FD&C Act Sections 744H-744J |
| MDUFA Fee Authority | FD&C Act Section 738 |
| Annual Fee Notice | Federal Register (published annually by August 1) |
| Fee Waivers | FD&C Act Section 736(d) |
| Orphan Drug Act | FD&C Act Section 526 |
| FDASIA (GDUFA/BSUFA original) | Pub. L. 112-144, July 9, 2012 |
| MDUFMA (MDUFA original) | Pub. L. 107-250, October 26, 2002 |
| BPCIA (Biosimilar pathway) | Pub. L. 111-148, Section 7002, March 23, 2010 |
References
Sources
- Prescription Drug User Fee Amendments | FDA
- Generic Drug User Fee Amendments | FDA
- Biosimilar User Fee Amendments | FDA
- Medical Device User Fee Amendments (MDUFA): Fees | FDA
- 21 U.S.C. 379g | Legal Information Institute
- 21 U.S.C. 379j-41 | Legal Information Institute
- 21 U.S.C. 379j-51 | Legal Information Institute
- 21 U.S.C. 379j | Legal Information Institute
- Orphan Drug Designation and Exemption | FDA