FDA Releases Draft GDUFA IV, PDUFA Commitment Letters for FY 2028-2032

The U.S. Food and Drug Administration (FDA) released two draft commitment letters for the next iterations of the Generic Drug User Fee Act (GDUFA) and Prescription Drug User Fee Act (PDUFA), covering fiscal years (FYs) 2028 to 2032. The draft letters were published in the Federal Register on August 11 and August 14, 2026, respectively, and mark the next step in reauthorizing the four human product user fee programs before the September 30, 2027, expiration date. If adopted and finalized by Congress, the letters would establish new financial incentives for domestic manufacturing, streamline communications, and enhance transparency of the FDA's review processes, staffing capacity, and finances.

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 based on public input before transmitting the formal commitment letters to Congress, which must pass legislation to formally reauthorize the user fee amendments.

The draft GDUFA commitment letter includes 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. 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. These 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 for FDA written responses. Face-to-face meetings or written responses may be requested.

GDUFA IV also proposes enhanced Abbreviated New Drug Application (ANDA) transparency and communication enhancements. A new feature 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, updated by the end of each FY thereafter, with plans to seek public input on potential future improvements.

Generic drug sponsors also appear to be exploring an idea to increase postmarketing commitments for their products, which could help increase first-cycle approvals and reduce overall review times, though the FDA has questions about the proposal.