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  5. Completed PDUFA VII Deliverables
  1. Prescription Drug User Fee Amendments

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
Report Real-World Evidence Submissions to CBER and CDER Real-World Evidence 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
 
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