Completed PDUFA VII Deliverables
Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, user fees have played an important role in expediting the drug approval process while ensuring their safety and efficacy. PDUFA must be reauthorized every five years, and in September 2022, the President signed into law the sixth reauthorization of PDUFA, which establishes the program through fiscal year 2027. To provide a snapshot of how FDA is meeting some of its PDUFA commitments, the following tables present a listing of required and completed deliverables. Many of these deliverables can be found elsewhere on FDA's website but have been consolidated here for ease of access.
Please note:
- The tables focus on external activities or deliverables such as guidances, public meetings, public workshops, and updates or documents posted to the FDA website.
- The tables include the original deliverables FDA produced to meet its commitments, but they do not necessarily include more recent versions that may have posted after the deliverables were met.
- For more detailed and complete information regarding PDUFA performance progress, please see the PDUFA Annual Performance Report page.
Recurring Commitments
This table includes commitments that require regular updates (e.g., annually, quarterly).
| Commitment | Topic | Recurrence |
|---|---|---|
| Publish Quarterly Hiring Updates | Set Clear Goals for Human Drug Review Program Hiring | Quarterly |
| Publish Data Standards Action Plan | Enhance Transparency | Quarterly |
| Electronic Submissions Gateway (ESG) Website Updates | Monitor and Modernize ESG | Annually |
| Publish Five-Year Financial Plan and Annual Updates | Financial Transparency | Annually |
| Report Real-World Evidence Submissions to CBER and CDER | Advancing Real-World Evidence for Use in Regulatory Decision-Making | Annually |
| Develop and Update Data and Tech Modernization Strategy | Develop Data and Technology Modernization Strategy | Annually |
| Publish Capacity Planning Implementation Plan and Updates | Resource Capacity Planning Implementation | Annually |
Other Commitments
This table includes other commitments, that do not have a regular update (e.g., guidances, public meetings).
| Commitment | Topic | Date Published |
|---|---|---|
| Publish Draft, Revised, or Final Guidance on Digital Health Technologies | Enhancing Use of Digital Health Technologies to Support Drug Development and Review | 12/21/2021 |
| Launch Rare Disease Endpoint Advancement Pilot Program | Advancing Development of Drugs for Rare Diseases | 9/30/2022 |
| Develop STAR webpage | Split Real Time Application Review (STAR) Pilot Program | 10/1/2022 |
| Publish FRN on Paired Meeting Program | Enhancing Capacity to Review Complex Innovative Designs | 10/20/2022 |
| Publish FRN Announcing CMC Development and Readiness Pilot | Facilitating Chemistry, Manufacturing, and Controls Readiness for Products with Accelerated Clinical Development | 10/31/2022 |
| Publish MAPP on Approaches to Meet CMC Challenges | Facilitating Chemistry, Manufacturing, and Controls Readiness for Products with Accelerated Clinical Development | 11/1/2022 |
| Patient-Focused Drug Development Listening Meeting on Gene Therapy Products | Patient-Focused Drug Development | 11/15/2022 |
| Publish FRN on Continuation of MIDD | Advancing Model-Informed Drug Development | 1/11/2023 |
| Conduct DHT Public Meeting 1 | Enhancing Use of Digital Health Technologies to Support Drug Development and Review | 1/31/2023 |
| Publish Website of DHT Committee | Enhancing Use of Digital Health Technologies to Support Drug Development and Review | 2/28/2023 |
| Conduct Public Workshop on Negative Controls | Optimization of the Sentinel Initiative | 3/8/2023 |
| Establish DHT Framework Document | Enhancing Use of Digital Health Technologies to Support Drug Development and Review | 3/23/2023 |
| Issue RFI for PFDD | Enhancing the Incorporation of the Patient’s Voice in Drug Development and Decision-Making | 5/2/2023 |
| Conduct Innovative Manufacturing Public Workshop | Advancing Utilization and Implementation of Innovative Manufacturing | 6/8/2023 |
| Conduct Public Meeting Financial Plan FY23 | Financial Transparency | 6/8/2023 |
| Update Four-Part Harmony MAPP | Enhancing Communication Between FDA and Sponsors During Application Review | 8/25/2023 |
| Conduct Public Workshop on Post Market Pregnancy Data | Optimization of the Sentinel Initiative | 9/18/2023 |
| Publish Draft, Revised, or Final Guidance on Drug Use Related Software | Enhancing Use of Digital Health Technologies to Support Drug Development and Review | 9/19/2023 |
| Publish Revised Draft Guidance on Formal Meetings Between FDA and Sponsors | Guidance, Clarity, and Transparency | 9/22/2023 |
| Publish Draft Guidance on Alternative Tools to Assess Manufacturing Facilities | Alternative Tools to Assess Manufacturing Facilities Named in Pending Applications | 9/22/2023 |
| Issue Federal Register Notice Summarizing PFDD RFI | Enhancing the Incorporation of the Patient’s Voice in Drug Development and Decision-Making | 12/13/2023 |
| Publish Public Report on Challenges and Barriers to Cloud Technologies | Leverage Cloud Technology to Progress Regulatory Digital Transformation | 12/27/2023 |
| Conduct Public Workshop for CID | Enhancing Capacity to Review Complex Innovative Designs | 3/5/2024 |
| Issue New Policies and Procedures for Reviewing Methodological Approaches and Study Protocols for REMS | Modernization and Improvement of REMS Assessments | 3/25/2024 |
| Update Existing Policies and Procedures to Systematically Determine if Modifications to REMS are Needed | Modernization and Improvement of REMS Assessments | 3/25/2024 |
| Update Relevant REMS Guidances to Incorporate REMS Assessment Planning into the Design of REMS | Modernization and Improvement of REMS Assessments | 5/6/2024 |
| Initiate Pregnancy Safety Demonstration Projects | Optimization of the Sentinel Initiative | 5/8/2024 |
| Conduct Public Meeting Financial Plan FY24 | Financial Transparency | 6/6/2024 |
| Conduct DHT Public Meeting 2 | Enhancing Use of Digital Health Technologies to Support Drug Development and Review | 6/25/2024 |
| Publish Combination Products Guidance Related to URRAs | Advancing Development of Drug-Device and Biologic-Device Combination Products Regulated by CBER and CDER for Use-Related Risk Analysis (URRA) | 7/8/2024 |
| Publish Report on Public Workshop on Post Market Pregnancy Data | Optimization of the Sentinel Initiative | 7/11/2024 |
| Hold Public Workshop About Meetings Management | Promoting Innovation Through Enhanced Communication Between FDA and Sponsors During Drug Development | 7/22/2024 |
| Issue RFI for MIDD | Advancing Model-Informed Drug Development | 9/3/2024 |
| Publish Strategy Document on Innovative Manufacturing Technologies | Advancing the Use and Implementation of Innovative Manufacturing Technologies | 9/11/2024 |
| Publish Draft Q&A Guidance on Cell and Gene Therapy | Novel Approaches to Development of Cell and Gene Therapy | 11/19/2024 |
| Conduct PFDD Methodology Workshop 1 | Enhancing the Incorporation of the Patient’s Voice in Drug Development and Decision-Making | 12/13/2024 |
| Publish Public Report on Assessment of Communication Through Product Quality Information Requests | Enhancing Communication Between FDA and Sponsors During Application Review | 5/30/2025 |
| Publish Independent Assessment of Hiring Report | Comprehensive and Continuous Assessment of Hiring and Retention | 8/25/2025 |
| Conduct Public Workshop on CMC Development and Readiness Pilot, Including Case Studies of Lessons Learned | Facilitating Chemistry, Manufacturing, and Controls Readiness for Products with Accelerated Clinical Development | 9/10/2025 |
| Publish Final Guidance on Alternative Tools to Assess Manufacturing Facilities | Alternative Tools to Assess Manufacturing Facilities Named in Pending Applications | 9/12/2025 |
| Conduct Public Meeting on Perspectives of Cell and Gene Therapy Manufacturers | Leveraging Knowledge | 9/18/2025 |
| Conduct PFDD Methodology Workshop 2 | Enhancing the Incorporation of the Patient’s Voice in Drug Development and Decision-Making | 9/19/2025 |
| Hold Public Meeting for Independent Assessment Hiring | Comprehensive and Continuous Assessment of Hiring and Retention | 9/24/2025 |
| Publish Update on Public and Sponsor Access to Sentinel | Optimization of the Sentinel Initiative | 9/24/2025 |
| Publish Draft Guidance on Evaluation of Efficacy in Small Patient Populations Using Novel Trial Designs | Novel Approaches to Development of Cell and Gene Therapy | 9/25/2025 |
| Publish Draft Guidance on Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data for Cell and Gene Therapy Products | Novel Approaches to Development of Cell and Gene Therapy | 9/25/2025 |
| Update the Guidance for Industry: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions | Expedited Programs for the Development of Regenerative Medicine Therapies | 9/25/2025 |
| Publish Resource Capacity Planning Assessment Report | Resource Capacity Planning Assessment | 9/26/2025 |
| Publish Report on Use of Sentinel | Optimization of the Sentinel Initiative | 9/30/2025 |
| Conduct Public Meeting Financial Plan FY25 | Financial Transparency | 9/30/2025 |
| STAR Pilot Program Assessment | Split Real Time Application Review (STAR) Pilot Program | 1/13/2026 |