PDUFA VIII: Fiscal Years 2028 – 2032
In September 2022, the FDA User Fee Reauthorization Act of 2022 (FDAUFRA) was enacted, which included the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA). The current legislative authority for PDUFA VII expires in September 2027. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years to fund the process for the review of prescription drug product applications.
Information related to FDA’s preparation for the seventh reauthorization of PDUFA will be hosted here on this page as it becomes available.
PDUFA VIII Reauthorization Kickoff Public Meeting - July 14, 2025
The Food and Drug Administration hosted a public meeting on July 14, 2025 to kick off the process for reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032.
Industry and Stakeholder Discussions on Reauthorization
FDA will develop proposed enhancements for PDUFA VIII in consultation with drug industry representatives, patient and consumer advocates, health care professionals, and other public stakeholders. The notes from FDA’s discussions with industry and other stakeholders will be posted on this webpage as they become available.
Industry Discussions on Reauthorization
| Subgroup | Date | Topics |
|---|---|---|
| Pre-Market | 12/2/2025 | Approach to FDA’s MIDD Proposal; Approach to FDA’s Rare Disease Proposal; FDA-Industry Discussion on Industry’s Facilitate First Cycle Reviews Proposal; Next Steps |
| Nonprescription Drug Products | 12/2/2025 | Proposal 1: Expansion of the Special Protocol Assessment (SPA) Program for Nonprescription Studies; Proposal 2: Stepwise Labeling Review Process; Next Steps |
| Pre-Market | 12/4/2025 | Confirm Approach to FDA’s MIDD Proposal; Approach to Incorporate Regulatory Science into Regulatory Decision-Making Proposal; Approach to FDA Meetings Management Proposal; Next Steps |
| Post-Market Safety | 12/4/2025 | Topic 1: Sentinel's Contributions to Regulatory Decision Making and Supporting the Use of Real-World Evidence; Topic 2: Resources Allocated for the Sentinel System under PDUFA VI and PDUFA VII and FDA Proposal for the Maintenance of Sentinel Capabilities; Next Steps |
| Finance | 12/9/2025 | FDA Framework; Wrap Up and Next Steps |
| Finance | 12/4/2025 | Follow-up Discussion from Last Meeting; Operating Reserve Adjustment; Triggers; Wrap-Up and Next Steps |
| CMC | 12/2/2025 | Prior Approval Supplement (PAS) Timelines; Facility Lifecycle; Next Steps |
| Finance | 11/20/2025 | Follow Up Discussion; Technical Changes; Technical Changes – Program Fee Eligibility Date; Next Steps |
| Finance | 12/2/2025 | Administrative Efficiencies; Wrap-Up and Next Steps |
| Steering Committee | 12/11/2025 | Subgroup Progress Updates; Next Steps |
| Steering Committee | 11/4/2025 | Expectations and Ground Rules; PDUFA Program Background and Context; Schedule and Logistics; Next Steps |
| CMC | 11/4/2025 | Prior Approval Supplement (PAS) Timelines; Facility Lifecycle; Next Steps |
| Finance | 11/4/2025 | PDUFA Finance Group Role and Process Discussion; FDA Financial Perspective; FDA Proposals; Industry Proposals; Next Steps |
| Pre-Market | 11/4/2025 | Ground Rules; Industry Pre-Market Proposal Presentation; FDA Pre-Market Proposal Presentation; Next Steps |
| Nonprescription Drug Products | 11/4/2025 | Proposal 1: Expansion of the SPA Program for Nonprescription Studies; Proposal 2: Stepwise Labeling Review Process; Proposal 3: Use of Post-Market Commitments for Labeling Elements; Next Steps |
| Post-Market Safety | 11/5/2025 | Opening Remarks and Sentinel PDUFA VIII Proposal; Sentinel 3.0 System Evolution and Architecture; Real-World Evidence (RWE) and PDUFA VII Commitments; Clarifying Future and Past Resource Allocation; Agenda Topics for Upcoming FDA and Industry Post-Market Safety Subgroup Discussions |
| Steering Committee | 11/6/2025 | Fee Incentives for Domestic Drug Development; Subgroup Progress Updates; Next Steps |
| Finance | 11/6/2025 | FDA Proposals; Industry Proposal; Fee and Revenue Primer; Next Steps |
| Pre-Market | 11/6/2025 | Clarifying Questions on Proposals; Schedule of Proposal Topics Discussion; Next Steps |
| Nonprescription Drug Products | 11/12/2025 | Proposal 1: Expansion of Special Protocol Assessment (SPA) Program for OTC Studies; Proposal 2: Stepwise Labeling Review Process; Proposal 3: Use of Post-Market Commitments for Labeling Elements; Next Steps |
| CMC | 11/12/2025 | Prior Approval Supplement (PAS) Timelines; Facility Lifecycle; Industry Proposal Slides; Next Steps |
| Pre-Market | 11/13/2025 | FDA Detailed Pre-Market Proposal Presentation; Industry Questions on FDA Proposals; Confirming Schedule of Proposal Topics Discussions; Next Steps |
| Finance | 11/13/2025 | FDA Proposals: Enhancing Operating Reserve Adjustment Flexibility, Harmonizing Triggers for Efficiency and Resilience, Patch Test Exemption; Other Topics; Next Steps |
| Steering Committee | 11/13/2025 | Feedback on FDA's America First Fee Incentives for Drug Development Proposal; Update on Logistics; Subgroup Progress Updates; Next Steps |
| Steering Committee | 11/18/2025 | Goals for the End of the Calendar Year; FDA Proposal: Limit Small Business Waiver to U.S.-Based Applicants; Next Steps |
| Nonprescription Drug Products | 11/18/2025 | Proposal 1: Expansion of the Special Protocol Assessment (SPA) Program for Nonprescription Studies; Proposal 2: Stepwise Labeling Review Process; Proposal 3: Use of Post-Market Commitments for Labeling Elements; Next Steps |
| Finance | 11/18/2025 | Fixing Fee Loopholes; Planning Session; Next Steps |
| Pre-Market | 11/18/2025 | Industry Questions on FDA’s Meetings Management and Rare Disease Proposals; Approach to Industry’s Facilitate First Cycle Review Proposal; Next Steps |
| CMC | 11/18/2025 | Prior Approval Supplement (PAS) Timelines; Facility Lifecycle; Next Steps |
| Steering Committee | 11/20/2025 | Stakeholder Meeting Summary; Subgroup Progress Updates; Next Steps |
| Post-Market Safety | 11/20/2025 | Topic 1: PDUFA VII Demonstration Projects - Pregnancy Safety; Topic 2: PDUFA VII Demonstration Projects - Negative Controls; Topic 3: Sentinel 3.0 System Architecture and Evolution; Topic 4: Resource Allocation and PDUFA VIII Planning; Topic 5: Future Negotiations Framework; Next Steps |
| Pre-Market | 11/20/2025 | Approach to Split Real Time Application Review (STAR) Pilot Program; Approach to Complex Innovative Designs (CID) Program; Discussion of Industry Proposal: Improve FDA-Sponsor Interactions and FDA Proposal: Meetings Management; Discussion of Industry Proposal: Incorporate Regulatory Science in Regulatory Decision Making; Next Steps |
| Pre-Market | 11/25/2025 | Approach to FDA’s CID Proposal; Approach to FDA’s Advancing RWE Pilot Program Proposal; FDA-Industry Discussion on Advancing Real-World Evidence Pilot Program Proposal; Next Steps |
| Steering Committee | 12/4/2025 | FDA Proposal: Information Technology; Subgroup Progress Updates; Next Steps |
| Steering Committee | 12/9/2025 | FDA Proposal: Cell and Gene Therapy; Next Steps |
| Pre-Market | 12/9/2025 | Approach to Advancing RWE Proposal; Approach to Rare Disease Proposal; Approach to Facilitate First Cycle Reviews Proposal; Next Steps |
| CMC | 12/9/2025 | Facility Lifecycle; Prior Approval Supplement (PAS) Timelines; Next Steps |
| Nonprescription Drug Products | 12/9/2025 | Proposal 1: Expansion of the Special Protocol Assessment (SPA) Program for Nonprescription Studies; Proposal 2: Stepwise Labeling Review Process; Next Steps |
| Post-Market Safety | 12/10/2025 | Topic 1: ARIA Sufficiency Determinations; Topic 2: Industry Counterproposal to FDA’s Proposed PDUFA VIII Commitments; Next Steps |
| Pre-Market | 12/11/2025 | Approach to Rare Disease Proposal; Approach to Incorporate Regulatory Science into Regulatory Decision-Making Proposal; Approach to Enhancing Transparency and Consistency Related to PED Proposal; FDA Proposed Change to Streamlining Review of Certain Efficacy Supplements Proposal; Industry Counterproposal to Facilitating First Cycle Reviews Subproposal; Next Steps |
| Finance | 12/11/2025 | Trigger – Technical Changes to Statutory Language; Fixing Fee Loopholes Proposal; Wrap-Up and Next Steps |
| Finance | 12/16/2025 | Industry Proposed Model/Concept; Wrap-Up and Next Steps |
| Pre-Market | 12/16/2025 | Approach to Rare Disease Proposal; Approach to Enhancing Transparency and Consistency Related to Patient Experience Data (PED) Proposal; Approach to FDA Meetings Management and Industry Improve FDA-Sponsor Interactions Proposals; Next Steps |
| CMC | 12/16/2025 | Facility Lifecycle; Next Steps |
| Post-Market Safety | 12/17/2025 | Topic 1: Resource Allocations for Sentinel from PDUFA VI and VII; Topic 2: FDA Preliminary Response to Industry Counterproposal; Next Steps |
| Nonprescription Drug Products | 12/17/2025 | Proposal 2: Stepwise Labeling Review Process; Next Steps |
| Steering Committee | 12/18/2025 | Stakeholder Meeting Summary; Approach to Information Technology (IT) and Cell and Gene Therapy (CGT); Subgroup Progress Updates; Wrap Up |
| Pre-Market | 12/18/2025 | Negotiations Progress Discussion; Approach to CID Commitment Letter Language; Industry Response to Meetings Management Proposal; Industry Response to FDA Perspectives on Improve FDA-Sponsor Interactions Proposal; Approach to Meetings Management and Improve FDA-Sponsor Interactions Proposals; Next Steps |
| Nonprescription Drug Products | 1/6/2026 | Proposal 2: Stepwise Labeling Review Process; Next Steps |
| Steering Committee | 1/6/2026 | Goals and Schedule for the New Year; Next Steps |
| Finance | 1/6/2026 | PDUFA VIII Ledger; FDA Response to Industry Framework; Operating Reserve Adjustment (ORA); Wrap-Up and Next Steps |
| Pre-Market | 1/6/2026 | Approach to Meetings Management and Improve FDA-Sponsor Interactions Proposals; Approach to Advancing RWE Proposal; Approach to DDT and Benefit Risk Assessment Draft Commitment Letter Language; Approach to Rare Disease Proposal; Next Steps |
| CMC | 1/6/2026 | Facility Lifecycle; Next Steps |
| Post-Market Safety | 1/7/2026 | Topic 1: Draft Commitment Language; Next Steps |
| Steering Committee | 1/8/2026 | Approach to PDUFA VIII Finances; Subgroup Progress Updates; Wrap Up |
| Pre-Market | 1/8/2026 | Approach to DDT and Benefit Risk Assessment Draft Commitment Letter Language; Approach to Improve FDA-Sponsor Interactions and Meetings Management Proposals; Approach to Facilitate First Cycle Reviews Proposal; Next Steps |
| Finance | 1/8/2026 | Continue Discussion on FDA Response: Operating Reserve Adjustment; Capacity Planning Adjustment (CPA); Wrap-Up and Next Steps |
Stakeholder Discussions on Reauthorization
| Date | Topics |
|---|---|
| 11/7/2025 | Welcome and Period Consultation Series Overview; PDUFA Accomplishments and Reauthorization Process; Meeting Structure, Communication and Information Sharing Challenges; Stakeholder Perspectives on Topics for Future Meetings; Next Steps |
| 12/5/2025 | Model-Informed Drug Development (MIDD) Paired Meeting Program; Advancing Real World Evidence (RWE) Pilot; Rare Disease Endpoint Advancement (RDEA) Pilot; Biomarker Qualification Program (BQP); Complex Innovative Trial Design (CID) Meeting Program; Split Real-Time Application Review (STAR) Pilot Program; Next Steps |
| 1/9/2026 | PFDD: Patient-Focused Drug Development; Post-Market Safety: Sentinel Initiative; Post-Market Safety: Risk Evaluation and Mitigation Strategies (REMS) Assessment & Post Marketing Requirements (PMRs); Orphan Drug Exceptions & Exemptions; Next Steps |