PDUFA VIII: Fiscal Years 2028 – 2032

Pre-Market12/2/2025Approach to FDA’s MIDD Proposal; Approach to FDA’s Rare Disease Proposal; FDA-Industry Discussion on Industry’s Facilitate First Cycle Reviews Proposal; Next StepsNonprescription Drug Products12/2/2025Proposal 1: Expansion of the Special Protocol Assessment (SPA) Program for Nonprescription Studies; Proposal 2: Stepwise Labeling Review Process; Next StepsPre-Market12/4/2025Confirm Approach to FDA’s MIDD Proposal; Approach to Incorporate Regulatory Science into Regulatory Decision-Making Proposal; Approach to FDA Meetings Management Proposal; Next StepsPost-Market Safety12/4/2025Topic 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 StepsFinance12/9/2025FDA Framework; Wrap Up and Next StepsFinance12/4/2025Follow-up Discussion from Last Meeting; Operating Reserve Adjustment; Triggers; Wrap-Up and Next StepsCMC12/2/2025Prior Approval Supplement (PAS) Timelines; Facility Lifecycle; Next StepsFinance11/20/2025Follow Up Discussion; Technical Changes; Technical Changes – Program Fee Eligibility Date; Next StepsFinance12/2/2025Administrative Efficiencies; Wrap-Up and Next StepsSteering Committee12/11/2025Subgroup Progress Updates; Next StepsSteering Committee11/4/2025Expectations and Ground Rules; PDUFA Program Background and Context; Schedule and Logistics; Next StepsCMC11/4/2025Prior Approval Supplement (PAS) Timelines; Facility Lifecycle; Next StepsFinance11/4/2025PDUFA Finance Group Role and Process Discussion; FDA Financial Perspective; FDA Proposals; Industry Proposals; Next StepsPre-Market11/4/2025Ground Rules; Industry Pre-Market Proposal Presentation; FDA Pre-Market Proposal Presentation; Next StepsNonprescription Drug Products11/4/2025Proposal 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 StepsPost-Market Safety11/5/2025Opening 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 Committee11/6/2025Fee Incentives for Domestic Drug Development; Subgroup Progress Updates; Next StepsFinance11/6/2025FDA Proposals; Industry Proposal; Fee and Revenue Primer; Next StepsPre-Market11/6/2025Clarifying Questions on Proposals; Schedule of Proposal Topics Discussion; Next StepsNonprescription Drug Products11/12/2025Proposal 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 StepsCMC11/12/2025Prior Approval Supplement (PAS) Timelines; Facility Lifecycle; Industry Proposal Slides; Next StepsPre-Market11/13/2025FDA Detailed Pre-Market Proposal Presentation; Industry Questions on FDA Proposals; Confirming Schedule of Proposal Topics Discussions; Next StepsFinance11/13/2025FDA Proposals: Enhancing Operating Reserve Adjustment Flexibility, Harmonizing Triggers for Efficiency and Resilience, Patch Test Exemption; Other Topics; Next StepsSteering Committee11/13/2025Feedback on FDA's America First Fee Incentives for Drug Development Proposal; Update on Logistics; Subgroup Progress Updates; Next StepsSteering Committee11/18/2025Goals for the End of the Calendar Year; FDA Proposal: Limit Small Business Waiver to U.S.-Based Applicants; Next StepsNonprescription Drug Products 11/18/2025Proposal 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 StepsFinance11/18/2025Fixing Fee Loopholes; Planning Session; Next StepsPre-Market11/18/2025Industry Questions on FDA’s Meetings Management and Rare Disease Proposals; Approach to Industry’s Facilitate First Cycle Review Proposal; Next StepsCMC11/18/2025Prior Approval Supplement (PAS) Timelines; Facility Lifecycle; Next StepsSteering Committee11/20/2025Stakeholder Meeting Summary; Subgroup Progress Updates; Next StepsPost-Market Safety11/20/2025Topic 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 StepsPre-Market11/20/2025Approach 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 StepsPre-Market11/25/2025Approach 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 StepsSteering Committee12/4/2025FDA Proposal: Information Technology; Subgroup Progress Updates; Next StepsSteering Committee12/9/2025FDA Proposal: Cell and Gene Therapy; Next StepsPre-Market12/9/2025Approach to Advancing RWE Proposal; Approach to Rare Disease Proposal; Approach to Facilitate First Cycle Reviews Proposal; Next StepsCMC12/9/2025Facility Lifecycle; Prior Approval Supplement (PAS) Timelines; Next StepsNonprescription Drug Products12/9/2025Proposal 1: Expansion of the Special Protocol Assessment (SPA) Program for Nonprescription Studies; Proposal 2: Stepwise Labeling Review Process; Next StepsPost-Market Safety12/10/2025Topic 1: ARIA Sufficiency Determinations; Topic 2: Industry Counterproposal to FDA’s Proposed PDUFA VIII Commitments; Next StepsPre-Market12/11/2025Approach 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 StepsFinance12/11/2025Trigger – Technical Changes to Statutory Language; Fixing Fee Loopholes Proposal; Wrap-Up and Next StepsFinance12/16/2025Industry Proposed Model/Concept; Wrap-Up and Next StepsPre-Market12/16/2025Approach 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 StepsCMC12/16/2025Facility Lifecycle; Next StepsPost-Market Safety12/17/2025Topic 1: Resource Allocations for Sentinel from PDUFA VI and VII; Topic 2: FDA Preliminary Response to Industry Counterproposal; Next StepsNonprescription Drug Products12/17/2025Proposal 2: Stepwise Labeling Review Process; Next StepsSteering Committee12/18/2025Stakeholder Meeting Summary; Approach to Information Technology (IT) and Cell and Gene Therapy (CGT); Subgroup Progress Updates; Wrap Up