PDUFA VIII Pushes Forward: Proposed Commitment Letter Outlines Updates to Drug Review Process

August 26, 2026 | Reading Time: 10+ min

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PDUFA VIII Pushes Forward: Proposed Commitment Letter Outlines Updates to Drug Review Process

August 26, 2026

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PDUFA VIII Pushes Forward: Proposed Commitment Letter Outlines Updates to Drug Review Process

By: Anna K. Abram, Nathan A. Brown, Kandis McClure

Background

Earlier this month, the U.S. Food and Drug Administration (FDA) released the proposed Prescription Drug User Fee Act (PDUFA) VIII commitment letter marking a pivotal milestone on the path to the seventh reauthorization of the agency’s program authorizing FDA to collect user fees to supplement the costs for the review of human drug applications. PDUFA VIII would span fiscal years 2028 through 2032, as the current authorization (PDUFA VII) is set to expire at the end of Fiscal Year 2027 (September 30, 2027). Congress will need to take legislative action to continue the PDUFA program after that date.

A key objective of PDUFA, and every reauthorization since its initial enactment in 1992, is to improve regulatory predictability regarding the development and review of human drug applications through performance goals and timelines for certain types of regulatory meetings and aligning user fee resources with the agency’s anticipated workload for related activities. The overarching goal is to foster a predictable path for the process for considering drug applications in a modern, timely and efficient manner. While PDUFA does not presuppose any regulatory outcome for applications, the commitment letter describes specific performance goals and timelines for review activities and proposes actions related to specific guidance documents, assessments, and pilot programs in furtherance of advancing a modern and efficient drug review program and building on PDUFA VII.

In releasing the commitment letter, FDA also announced a public meeting on PDUFA VIII that will be held on September 16, 2026, and the opening of a docket for the public to submit comments on the commitment letter until October 16, 2026.  After the public meeting occurs and comment period closes, the next step in the reauthorization process will be for FDA to review the comments received, make revisions (as necessary) and submit the PDUFA commitment letter and recommendations to Congress by January 15, 2027.

The PDUFA VIII commitment letter reflects the culmination of more than a year of negotiations between the agency and regulated industry and consultations with stakeholders. This client alert highlights various areas of focus in the PDUFA VIII proposed commitment letter and related timelines where applicable. For additional details regarding specific performance goals and timelines please see the commitment letter in full available here.

Key Themes and Areas of Focus for PDUFA VIII

The PDUFA VIII commitment letter details performance goals and procedures across six areas of focus: 1) Ensuring the Effectiveness of the of the Human Drug Review Program; 2) Continued Enhancement of User Fee Resource Management; 3) Transparency in FDA Hiring and Retention of Review Staff for the Human Drug Review Program; 4) Information Technology Goals; 5) Improving FDA Performance Management; and 6) Progress Reporting For PDUFA VIII and Continuing PDUFA VII Initiatives. Common themes within each of these areas of focus include  commitments intended to enhance the transparency, communication, efficiency and effectiveness of the human drug review program and promote timely regulatory decision making. The nature of the PDUFA reauthorizations is to build on the prior reauthorizations and PDUFA VIII is in keeping with that tradition. Many of the topics and themes of PDUFA VIII have been sustained areas of focus spanning multiple PDUFA reauthorizations. While these are not new themes or areas of focus for PDUFA, the proposed PDUFA VIII updates reflect what has been learned through implementation of PDUFA VII, anticipated needs over the next five years of the program, and the Trump administration’s focus on accelerating clinical trials and drug manufacturing in the United States. Aspects of PDUFA VIII highlighted in the Federal Register Notice include the following items.

  • Assessment of the Program: FDA proposes a third-party assessment focused on first-cycle review. (See chart for further details.)
  • Pivotal Protocol Prioritization: FDA proposes implementing a process for prioritizing review of submitted pivotal protocols for studies intended to form the primary basis of an efficacy claim for an application by which sponsors would identify relevant submissions as “Pivotal Protocols” in the cover letter and FDA will prioritize review of such protocols, with updates to relevant Manuals of Policies and Procedures (MAPPs) and Standard Operating Policies and Procedures (SOPPs).
  • Meeting Management Goals: FDA proposes highlighting the availability of multi-divisional meetings and introducing new processes for requesting and justifying meeting format. FDA further proposes to add a new process for sponsors to request that pre-IND, Type C, Type D, and INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER(Center for Biologics Evaluation and Research)/CDER (Center for Drug Evaluation and Research) ProducTs) meetings be held face-to-face and, if not granted in that format, for FDA to convey a specific rationale for why a written response is sufficient.
  • Expediting Drug Development and Enhancing the Use of Regulatory Science Tools: FDA proposes to expand the availability of regulatory science pilots and programs and incorporate those programs into review practice, including transitioning the Model-Informed Drug Development (MIDD) Paired Meeting Program to Type C-MIDD meetings and incorporating the Rare Disease Endpoint Advancement (RDEA) Pilot, Complex Innovative Trial Design (CID) Paired Meeting Program, and Advancing Real-World Evidence (RWE) Program into existing formal meeting requests. FDA is also proposing to introduce up to 10 Rare Disease Innovation, Science, and Exploration (RISE) workshops and publish case studies on how patient experience data was considered in regulatory decisions across different therapeutic areas. FDA also commits to hosting various public meetings on related topics. (See chart for further details.)
  • Enhancement and Modernization of the FDA Drug Safety System: FDA proposes continuing to dedicate user fees to enhance the drug safety system and related activities, including improving existing tools used in identifying and considering adverse events.
  • Advancing Chemistry, Manufacturing, and Controls (CMC) Facility Assessment: FDA proposes a risk-based lifecycle approach to identifying and addressing manufacturing facility deficiencies to facilitate a proactive approach through enhanced engagement mechanisms between FDA and the regulated industry that may happen before, during, and after an application review cycle. FDA also proposes to publish related guidance and conduct a third-party assessment and associated public workshop to assess the effectiveness of the facility lifecycle program and the impact of the program on facility-issue driven complete responses. (See chart for further details.)
  • Supporting Review of Allergenic Extract Products: FDA proposes that epicutaneous-test diagnostic products (“patch tests”) be exempt from the PDUFA program and fees beginning in PDUFA VIII.
  • Continued Enhancement of User Fee Resource Management: FDA proposes to continue to focus on optimal use of user fee resources and the alignment of staff to workload, through the Agency's resource capacity planning capability and publication of a 5-year financial plan and annual updates. FDA further proposes annual technical staff meetings with regulated industry and publishing the minutes from these meetings on its public website. FDA also proposes to partner with a third party to evaluate the operations of the PDUFA program. (See chart for further details.)
  • Enhancements to Fee Mechanisms: Proposed updates in PDUFA VIII include a process to assess whether any efficiencies identified in a planned assessment can be reflected in the revenue amounts (starting in fiscal year 2030), discontinuation of the Strategic Hiring and Retention Adjustment, limits on the use of the Capacity Planning Adjustment, discontinuation of the Additional Dollar Amounts, a reduction in the maximum operating reserve, and updates to the dollar amounts for the Additional Direct Costs. More specifically, the Enterprise Performance Adjustment (EPA) is part of the process proposed to identify whether efficiencies have been realized and, if so, whether those efficiencies should be reflected in the PDUFA program revenue amounts in fiscal years 2030-2032. (See chart for further details.)

    PDUFA VIII proposes a Personnel Compensation and Benefits (PC&B) Set-Aside by which the agency will reserve the funding needed to restaff the PDUFA program at a level consistent with fiscal year 2025. PDUFA VIII further proposes fee structure changes such that sponsors would receive a 50% reduction in the application fee if the application includes clinical data from at least one phase 1 trial anchored in the United States initiated after October 1, 2027. The agreement would also modify the fee structure to charge sponsors a fee, equal to 50% of the full application fee, for the first supplement seeking approval for a non-orphan indication for an application that was subject to the orphan application fee exception and limit the orphan program fee exemption to products approved only for orphan indications. In addition, PDUFA VIII proposes to update the eligibility for the small business waiver to only companies based in the United States.

  • Impact of PDUFA VIII Enhancements on User Fee Revenue: The agreement proposes reductions in target revenue resulting from ending limited-time operating costs under PDUFA VII and savings from administrative efficiencies and proposes to redirect existing resources to fund enhancements for PDUFA VIII and restaff the PDUFA program in targeted areas. The proposed base revenue amount reflects a reduction of about $56.0 million from savings from administrative efficiencies and an increase of about $7.8 million for net additional positions reflected by the PDUFA VIII agreement, with the net effect of a $48.3 million proposed reduction to the base revenue for PDUFA VIII.

Proposed PDUFA VIII Commitments & Timelines

An overview of various proposed guidance, study, report, assessment and pilot program deliverables and corresponding key dates in PDUFA VIII.

Ensuring the Effectiveness of the Human Drug Review Program

 

Deliverable

Key Dates

Assessment of the Program, Efficacy Supplement, and Communications (p. 11)

Beginning in FY 2028 and continuously through the end of the assessment, FDA will contract with an independent third party with expertise in assessing the quality and efficiency of the biopharmaceutical development and regulatory review programs to assess first cycle review processes, outcomes, and FDA-sponsor communications during first cycle review.

 
  • FDA will publish the statement of work for the assessment for public comment.
  • By March 31, 2030, FDA and the third party will publish an interim assessment report for public comment.
  • By June 30, 2030, FDA and the third party will hold a public workshop to discuss the interim assessment report.
  • By March 31, 2032, FDA and the third party will publish a final report on FDA’s public website. This report will include findings from the assessment as well as recommendations for increasing the effectiveness of FDA-sponsor communications and reducing complete responses, missed goal dates, and review clock extensions. The report will also incorporate feedback from the public workshop.

 

Meeting Management Goals:

Guidance, Clarity and Transparency (p. 24)

 





Assessment of Enhancements to Formal Meetings (p. 25)

Beginning in FY 2028, FDA will partner with a third party to assess the effectiveness of two enhancements introduced in PDUFA VIII: (1) requests for written responses and face-to-face meetings and (2) multi-divisional meetings. The third party will have expertise in assessing the quality and efficiency of regulatory review programs.

 
  • By September 30, 2028, FDA will issue a revised draft of the existing guidance on “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” with information pertaining to multi-divisional meeting requests and written response only procedures. In addition, FDA will update relevant MAPPs and SOPPs.

 

  • FDA and the third party will use the data to provide an assessment of the effectiveness of the enhancements and suggest actionable recommendations to help FDA and sponsors improve their communications.
  • By March 31, 2030, FDA will publish an interim assessment report for public comment.
  • By March 31, 2032, FDA will publish a final report on its public website. This report will include findings from the assessment as well as recommendations for increasing the effectiveness of these enhancements.

Expediting Drug Development and Enhancing the Use of Regulatory Science Tools: 

FDA will convene Rare Disease Innovation, Science, and Exploration (RISE) workshops to facilitate scientific exchange, identify challenges, and promote solutions that support efficient and effective development and review of therapies for rare diseases. (p. 27)

Continuation and transition of the Rare Disease Endpoint Advancement (RDEA) Pilot Program (p. 28)

 

 

 
  • FDA will convene up to 10 RISE workshops, at least one annually, from FY 2028-2032. FDA will publicly solicit topics for RISE Workshops, and the Workshops themselves will incorporate engagement from the regulated industry, academia, and patient advocates. After each RISE workshop, a publicly available summary will be prepared that includes recommended action items.
  • FDA will publish a Federal Register Notice no later than the end of the first quarter of FY 2028 announcing the continuation of the RDEA pilot program.
  • FDA will utilize a phased implementation to transition the RDEA pilot program to the established meeting framework. From FY 2028-2029, the RDEA pilot program will continue, and sponsors should submit proposals for potential participation. From FY 2030-2032, the RDEA pilot program will transition to Type C-RDEA meetings.
  • As part of RDEA, FDA will conduct up to 3 public workshops by the end of FY 2032 to discuss various topics relevant to endpoint development for rare diseases. To promote innovation and evolving science, novel endpoints developed through RDEA may be presented by FDA, such as in guidance documents, on a public-facing website, or at public workshops as case studies.

Model Informed Drug Development (MIDD) (p. 34)

 

 




Patient Focused Drug Development (PFDD) (p. 34)

 

 

 

 




Communicating the Use of Regulatory Science Tools (p. 36)

 

 
  • By no later than the end of the 1st quarter of FY 2028, FDA will publish a Federal Register Notice announcing the continuation of the MIDD meeting program and outline any updates to the process, scope of relevant meeting topics, and submission and response timelines.

 

  • FDA intends to publish case studies at least two times by the end of FY 2032 demonstrating how patient experience data was considered in specific regulatory decisions across different therapeutic areas, highlighting when patient experience data was used and when it was not used to inform regulatory decision-making.
  • FDA intends, by the end of FY 2030, to host a public meeting to discuss case studies and facilitate broader dialogue about the collection, submission, and use of patient experience data in drug development and regulatory review.

 

  • By the end of FY 2028, FDA will hold a public meeting to discuss best practices for communicating the use of regulatory science tools in drug development and regulatory decision-making.
  • Within 6 months of the public meeting, FDA will issue a summary report of the meeting that will include potentially actionable recommendations to the regulated industry and FDA on communication approaches to increase transparency and shared learnings across multiple stakeholders.

Advancing Chemistry, Manufacturing, and Controls (CMC) Facility Assessment: A Risk Based Lifecycle Approach

 

CMC Facility Lifecycle Workshop and Third-Party Assessment; Guidance (p. 42)

The public workshop will focus on program implementation and its impact on facility readiness and reduction of facility deficiencies. Topics for the workshop will be informed by the third-party assessment and include, but are not limited to, impact on the goals of inspection readiness and reduction in facility deficiencies, program operations and feedback from both FDA and the regulated industry on learnings to date.

 
  • FDA will contract with an independent third party to conduct a public workshop which will be held no later than September 30, 2030.
  • A third party will separately engage both FDA staff and individual sponsors through contractor-led interviews to assess the effectiveness of the facility lifecycle program. This third party will also assess the impact of the facility lifecycle program on facility-issue driven complete responses.
  • Following the close of the public comment period for the public workshop, the third-party that conducted the assessment described above will assess feedback from the workshop and draft a report summarizing the findings from the workshop, its assessment, and engagement with FDA and individual sponsors and identify best practices and areas for improvement for the regulated industry and FDA to enhance the CMC facility lifecycle program. The next steps may include proposed timeframes to develop or revise, as appropriate, relevant MAPPs or SOPPs and other applicable documents to incorporate lessons learned.
  • FDA will publish the final report on the FDA’s website no later than 9 months after the close of the comment period following the public workshop.
  • By October 1, 2028, FDA will strive to publish draft guidance describing the implementation of this CMC facility lifecycle program.

 Continued Enhancement of User Fee Resource Management

 

Deliverable

Key Dates

Financial Transparency: Five-Year Financial Plan (p. 45)

The plan and its annual updates will include discussion on shared services, financial and personnel related reporting.

Enterprise Performance Assessment (p. 46)

FDA will contract with an independent third party with expertise in evaluating regulatory program operations and organizational performance to conduct a comprehensive assessment of the PDUFA program.
  • FDA will publish a PDUFA 5-year financial plan no later than the end of the 2nd quarter of FY 2028.
  • FDA will publish updates to the 5-year plan no later than the end of the 2nd quarter of each subsequent fiscal year.

  • By March 31, 2029, FDA will publish a report in which the contractor documents its study design and methodology, findings, and recommendations. The report will be published for public comment and on FDA’s public website.
  • In the Federal Register Notice setting fees for FY 2030, FDA will publish its decision and rationale for an adjustment to be implemented, if any, including its expected schedule for fiscal years 2031 and 2032.

 

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