Opportunity
Federal Register #FDA-2026-N-8163
FDA Public Meeting on PDUFA Reauthorization and Drug Withdrawal Determinations
Buyer
Food and Drug Administration
Posted
August 14, 2026
Respond By
October 16, 2026
Identifier
FDA-2026-N-8163
The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is announcing a hybrid public meeting to discuss the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2028-2032. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - FDA (as the agency and regulator) - LASIX (furosemide) tablets (OEM: Sanofi, original NDA holder) - ANSAID (flurbiprofen) tablets (OEM: Pfizer, original NDA holder) - Products/Services Mentioned: - LASIX (furosemide) tablets, 20 mg, 40 mg, 80 mg (NDA 016273) - ANSAID (flurbiprofen) tablets, 50 mg, 100 mg (NDA 018766) - Public meeting service (hybrid format, 1 event) - Notable Requirements: - FDA determined LASIX and ANSAID tablets were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic drug applications referencing these products - The public meeting is for stakeholder input on PDUFA reauthorization, focusing on enhancements to drug review processes and user fee structures - No procurement of goods or services is requested; this is an informational and consultative event - Period of Performance: - PDUFA reauthorization covers fiscal years 2028-2032 - Public meeting scheduled for September 16, with a 30-day comment period - No purchase quantities or part numbers for procurement; only regulatory and informational details provided
Description
The Food and Drug Administration (FDA) is hosting a hybrid public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2028 through 2032. PDUFA authorizes FDA to collect user fees to support the review process of human drug applications. The current legislative authority expires in September 2027, requiring new legislation for continued fee collection. The meeting allows public presentation of views and a 30-day comment period to provide written feedback on the recommendations, which FDA will consider for possible revision.