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

 

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
Publish Capacity Planning Implementation Plan	Resource Capacity Planning Implementation	3/29/2023
Publish 5 Year Financial Plan	Financial Transparency	3/31/2023
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
Develop and Update Data and Technology Modernization Strategy FY23	Develop Data and Technology Modernization Strategy	9/19/2023
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
Publish Capacity Planning Implementation Plan Updates FY24	Resource Capacity Planning Implementation	3/22/2024
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