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ARTICLE · 19 AUGUST 2026

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

Holland & Knight
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The FDA has released draft commitment letters for GDUFA and PDUFA covering fiscal years 2028-2032, proposing significant changes including financial incentives for domestic manufacturing, streamlined communications, and enhanced transparency in drug review processes. These draft letters mark a critical step in reauthorizing the user fee programs before their September 2027 expiration, with public meetings scheduled for September 2026 to gather stakeholder input before Congress makes final determinations.

United StatesFood, Drugs, Healthcare, Life Sciences
Jordan Brossi
Jordan Brossi
Michael Werner
Michael Werner
Sara Klock
Sara Klock
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Highlights

  • The U.S. Food and Drug Administration (FDA) recently released 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 release of the draft commitment letters marks the next step in the process to reauthorize the four human product user fee programs in advance of the September 30, 2027, expiration date.
  • If adopted and finalized by the U.S. Congress, the draft commitment letters would establish new financial incentives for domestic manufacturing, streamline communications and enhance transparency of the FDA's review processes, staffing capacity and finances.

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