FDA Releases Draft GDUFA, PDUFA Commitment Letters as User Fee Reauthorizations Move Forward

The U.S. Food and Drug Administration (FDA) released two draft commitment letters containing numerous recommendations and commitments made with representatives from the generic and prescription drug industries over the past 12 months. The draft commitment letters for the Generic Drug User Fee Act (GDUFA) and Prescription Drug User Fee Act (PDUFA) were published in the Federal Register on August 11 and August 14, 2026, respectively, alongside the announcement of two public meetings for stakeholders to provide input on the draft recommendations.

Public meetings on the PDUFA and GDUFA draft commitment letters will be held on September 16 and September 17, 2026, respectively. Stakeholders must submit requests to speak by September 2 for the PDUFA meeting and September 3 for the GDUFA meeting. Written comments are due by October 16 for PDUFA and October 17 for GDUFA.

The FDA will review and make changes as needed based on public input at the meetings and comments submitted to the docket prior to transmitting the formal commitment letters to the U.S. Congress.

Background on GDUFA and PDUFA

The GDUFA and PDUFA set policies and procedures to support the FDA's review and approval of generic drug and prescription drug products, respectively. As detailed in a previous Holland & Knight alert, the User Fee Amendments (UFAs) are negotiated between the FDA and regulated industry and set fees for companies submitting applications to the FDA, which are designed to ensure the FDA has sufficient resources to conduct review activities. The agreements also contain "performance goals" to make sure the FDA uses those resources to reduce review time and regulate in a more transparent way. 

The draft GDUFA and PDUFA commitment letters may be subject to further or additional changes following the public meetings next month, and final determinations on language will be made by Congress, which must pass legislation to formally reauthorize the UFAs prior to their expiration on September 30, 2027.

GDUFA IV

The draft GDUFA commitment letter includes a number of program enhancements for fiscal years (FYs) 2028 to 2032, including several proposals regarding domestic production incentives in the form of reduced or eliminated fees for U.S. facilities that were discussed during formal consultation meetings between the FDA and generic drug stakeholders.

According to the commitment letter, the FDA will create four process-based categories for formal GDUFA meetings in FYs 2028 to 2032: Type 30, Type 60, Type 90 and Type 120. The categories align GDUFA meetings more closely with the PDUFA meeting naming structure and are designated for specific phases and goals within product development timelines. Each meeting type will have specific focuses, goals, formats and deadlines by which the FDA must provide a written response based on the type of submission and applicant. The new categories are intended to streamline FDA operations and communications with sponsors. Face-to-face meetings – either in person or by teleconference, depending on the meeting type – or written responses may be requested.

GDUFA IV proposed to enhance Abbreviated New Drug Application (ANDA) transparency and communication enhancements. A new feature of GDUFA IV is a potential six-month extension of goal dates for ANDAs if the applicant informs the FDA that the goal date for an original ANDA submission (or resubmission) will be missed by more than 60 days for any reason, including a complex regulatory issue.

To enhance transparency and support ANDA quality, the FDA will create a new public database for maximum daily dose values beginning FY 2028. The database will be updated by the end of each FY thereafter, with the FDA planning to seek public input on potential future improvements to the database such as using annual public meetings or other mechanisms to garner additional input. The new database on maximum daily dose values – used to set safety limits on certain impurities in drug products – will complement the FDA's existing database on inactive ingredients, which the FDA also agreed to enhance. Entries in the database will include the inactive ingredient name, route of administration, dosage form, chemical abstract service number and unique ingredient identifier.

Separately, the FDA will also conduct a public workshop annually to solicit input on topics to be included in an annual list of GDUFA IV regulatory science initiatives that will be posted publicly. To further enhance transparency, the FDA will publish monthly, quarterly and FY reporting and performance metrics.

One of the recommendations for GDUFA for FYs 2028 to 2032 falls in the vein of America First initiatives that the administration has pursued through various regulatory and legislative means. The draft commitment letter recommends increasing user fees for foreign facilities to offset costs of foreign inspections, increasing from $15,000 to $25,000. A one-time ANDA fee waiver will be offered to a U.S.-based sponsor using U.S.-only facilities as manufacturers of active pharmaceutical ingredients and finished dosage form entities.

Application fees also would be reduced and offset by a corresponding increase in program fees, with the draft final commitment letter reflecting the program's largest proposed decrease and increase, respectively. A portion of the fees will be reallocated to staffing and restaffing initiatives.

The FDA will allow sponsors to request inspections of domestic facilities for surveillance purposes prior to ANDA submission, with some restrictions. The FDA will also consider requests for inspections that meet certain conditions and are submitted at least nine months in advance of, but no more than 24 months prior to, the planned submission date. The FDA will grant or deny at least 90 percent within 30 days of receipt. A post-warning letter meeting may be requested at least six months after issuance, with an exception for a sponsor to request earlier if "beneficial to both parties."

The FDA will also conduct one technical meeting per year with generic drug industry stakeholders on finance oversight following reductions in force. The technical meeting will be held between the months of August and September, starting in 2028, following the publishing of a fee-setting notice in the Federal Register.

Finally, the FDA commits to modify various Manuals of Policies and Procedures, which provide internal guidance to Center for Drug Evaluation and Research (CDER) personnel on regulatory activities. The updates will address topics such as ANDA application review status, appropriate communications for ANDA submissions, the imminent action process, Type meetings and other topics.

PDUFA VIII

The PDUFA draft commitment letter includes program enhancements for FYs 2028 to 2032 and updates, as well as refinements to support CDER and Center for Biologics Evaluation and Research (CBER) review processes and transparency.

The FDA will establish a new program to enhance review transparency and communication on new molecular entity new drug applications and original biologics licensing applications. Beginning October 1, 2027, the program will maximize efficiency of first-cycle review processes and minimize follow-on review cycles. The new program will also set parameters for steps and process throughout the entire life cycle review continuum, including the pre-submission meeting, original application submission, mid-cycle communications and other steps in the process.

The FDA will contract with a third-party entity to complete a review of the first-cycle review process and assess the quality and efficiency of biopharmaceutical development. The third party will also evaluate labeling communications between the FDA and sponsor to assess the overall process.

Further transparency features of PDUFA VIII include quarterly meetings on program progress and challenges related to PDUFA implementation. Appropriate FDA leadership will participate in one meeting per year, with topics covering the use of cloud technology to process regulatory digital information, FDA Electronic Submissions Gateway Next Generation, data and technology modernization initiatives, among others.

The commitment letter largely retains – with certain exceptions – timeline and process expectations and requirements, including for PDUFA type meetings, as well as INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meetings. INTERACT meetings are intended for novel questions and challenges in early development. FDA recently released final guidance to clarify additional details regarding meeting categories and addressed that INTERACT meetings are not an appropriate meeting type for requestors who previously had a pre-investigational new drug (IND) meeting or filed an IND.

The draft commitment letter also highlights a continued focus on drugs for rare diseases. In FY 2028 to 2032, CDER rare disease staff will be integrated into review teams for rare disease development programs. They will also provide training to review staff on the development, review and approval of drugs for rare diseases to "familiarize review staff with challenges" associated with rare disease applications and promote best practices for rare disease drug reviews. The FDA will also continue patient and regulated industry group engagement and plans to convene up to 10 Rare Disease Innovation, Science, and Exploration workshops – at least one annually – from FY 2028 to 2032. Information on activities and the success of rare disease programs will be incorporated into PDUFA annual performance reports.

The Rare Disease Endpoint Advancement (RDEA) Program will also continue. The FDA will publish a notice confirming the program's continuation in the Federal Register by end of the first quarter of FY 2028. The FDA will use a phased implementation to transition the RDEA Program to the established meeting framework the FDA uses for other PDUFA meetings through FY 2029. The FDA will accept a maximum of four proposals for admission into RDEA in FY 2028 and a maximum of six proposals in FY 2029. The FDA will transition the RDEA pilot program to Type C-RDEA meetings from FYs 2030 to 2032 and will hold three public workshops by the end of 2032.

The commitment letter contains several provisions dedicated to reaffirming the FDA's commitment to support cell and gene therapy saying, "FDA will build on the success of the Cell and Gene Therapy Program (CGTP) to ensure that the next generation of cell and gene therapy products are developed and made available to patients in a timely manner. The Agency will retain and further strengthen its staff capacity and capability to create predictability, speed development, and meet the challenges and demands of this rapidly advancing field." Finally, the FDA will retain and further strengthen the expertise of staff working on cell and gene therapy products. CBER will advance approaches to evaluate efficacy in small patient groups and work with industry stakeholders.

A variety of features will be incorporated into regulatory reviews to support drug development and biomedical innovation. The FDA's Complex Innovative Trial Design program will be incorporated into standard review practice, allowing sponsors to seek advice on design and analysis of complex studies. Sponsors may request participation by relevant FDA subject matter experts in meetings. The FDA will also maintain PDUFA resources to support consistent review of digital health technologies, a key focus of the FDA and broader U.S. Department of Health and Human Services (HHS) leadership.

To further emphasize patient experience as a key pillar of the drug development process, the FDA intends to publish case studies twice a year by the end of FY 2032 that demonstrate whether and how FDA centers used patient experience data. By the end of FY 2030, the FDA will host a public meeting to discuss use of patient experience data and foster broader discussion, with specific case studies to be published in advance.

The FDA will continue real-world evidence (RWE) included in submissions and will report at least annually on RWE submissions to CDER and CBER. The report will describe application type, study design, summarize effectiveness for new indications and link to published documents, as appropriate.

The FDA will also seek to optimize the Sentinel Initiative and will explore the potential for allowing sponsors to voluntarily submit concept briefs on proposed approaches to address safety issues potentially subject to a post-marketing requirement. The FDA commits to streamline annual reporting and conduct meetings on the Initiative's progress biannually.

Regarding Chemistry, Manufacturing, and Controls (CMC), the FDA will publish guidance on manufacturing facility readiness attributes that must be met prior to evaluation and inspection no later than September 30, 2030. The FDA will contract with a third party to conduct a public workshop on implementation, the potential impact on facility readiness and deficiencies, and facility life cycle program assessment. By October 1, 2028, the FDA will "strive" to issue public guidance on CMC facility life cycle program implementation, touching on readiness for pre-approval inspection or pre-license inspection and finalizing the guidance within 24 months of the comment period closing.

The FDA will publish the PDUFA five-year financial plan no later than the second quarter of FY 2028 and make updates each subsequent year on shared services, financial and personnel reporting. To complement the process, the FDA will also complete one technical meeting with industry per year. The FDA will contract a third party to evaluate its regulatory program operations, the organizational performance of PDUFA programs and publish findings on the FDA website by March 31, 2029, for public comment. Finally, the FY 2030 Federal Register notice announcing fees will also include any decisions and rationale on fee adjustments.

Citing "high attrition" of FDA staff during PDUFA VII, the FDA commits to share updates on staffing and review functions and prioritize staffing to support PDUFA VIII enhancements.

Similar to the GDUFA commitment letter, the FDA offers a financial incentive to support domestic manufacturing. Specifically, the agency offers a 50 percent reduction in a user fee when an application includes clinical data from at least one Phase 1 trial "anchored in the United States" and initiated after October 1, 2027.

Looking Ahead

With the draft commitment letters for GDUFA and PDFUA released, the lion's share of the work on crafting final UFAs language will now fall to Congress. In the short term, stakeholders should carefully consider participation in either or both public meetings, or by written comment, in advance of the various deadlines to maintain engagement with the agency.

Stakeholders with priorities for potential inclusion in either GDUFA or PDUFA, or the two remaining UFA packages, should consider outreach to congressional committees with jurisdiction over the FDA to determine where priorities may merit additional congressional engagement or have the support of members.

The commitment letter for the Biosimilar User Fee Act program is the only outstanding human medical products user fee program that has not yet released its formal draft commitment letter, which is expected in the coming weeks.

Holland & Knight's Healthcare & Life Sciences Team is well versed in assisting stakeholders with public meetings, written comments and congressional advocacy and outreach as the legislative process moves forward.

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