FDA invites chat on PDUFA fee reauthorization meeting.
Published Date: 8/14/2026
Notice
Summary
The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032. PDUFA authorizes FDA to collect user fees to support the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations, as necessary.
Analyzed Economic Effects
5 provisions identified: 2 benefits, 2 costs, 1 mixed.
50% Application Fee Cut for U.S.-Anchored Phase 1 Data
If you sponsor drug applications, PDUFA VIII would give a 50% reduction in the application fee when the application includes clinical data from at least one Phase 1 trial anchored in the United States that was initiated after October 1, 2027. This change applies to PDUFA VIII (Fiscal Years 2028–2032) and reduces the fee charged to qualifying sponsors.
Small Business Waiver Limited to U.S. Companies
PDUFA VIII would narrow eligibility for the small business fee waiver so that only companies based in the United States (i.e., created or organized under State law) qualify for the waiver. This change would take effect under the PDUFA VIII framework (Fiscal Years 2028–2032).
Orphan Fee Exception Tightened; Supplement Fee Added
PDUFA VIII would limit the orphan program fee exemption to products approved only for orphan indications and would charge a fee equal to 50% of the full application fee for the first supplement seeking approval for a non-orphan indication when the original application had received an orphan application fee exception. These changes are proposed for PDUFA VIII (Fiscal Years 2028–2032).
Proposed Net Reduction of $48.3M to Base PDUFA Revenue
FDA proposes a net reduction of about $48.3 million to the PDUFA VIII base revenue amount, reflecting a $56.0 million reduction from administrative efficiencies offset by about $7.8 million for net additional positions. This change is part of the PDUFA VIII (Fiscal Years 2028–2032) revenue picture described in the proposal.
Patch Tests (Epicutaneous Diagnostics) Exempted From Fees
FDA proposes that epicutaneous-test diagnostic products (patch tests) be exempt from the PDUFA program and from paying PDUFA fees beginning in PDUFA VIII (Fiscal Years 2028–2032) to encourage development of these products. The exemption removes those products from the PDUFA fee requirements under the proposed framework.
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