Federal Register #FDA-2025-N-0873

FDA Public Meeting on GDUFA Reauthorization Recommendations

This opportunity involves a public meeting hosted by the Food and Drug Administration (FDA) to discuss the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years 2028 to 2032. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or vendors are named in this notice - No products or services are being procured or awarded - Purpose: - Gather public input on proposed recommendations for GDUFA reauthorization - Discuss statutory changes, including: - Increased foreign fee differential for Active Pharmaceutical Ingredient (API), Finished Dosage Form (FDF), and Contract Manufacturing Organization (CMO) facilities - One-time application fee waiver for eligible domestic applicants - Opportunities for domestic facilities to request inspections in advance of submissions - Enhancements to user fee resource management - Notable Requirements: - Focus on fee structure changes and process improvements for generic drug manufacturers - Open to public comments and participation - No procurement activity, contract, or award is associated with this notice

Description

The Food and Drug Administration (FDA) is hosting a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years 2028 to 2032. GDUFA authorizes FDA to assess and collect fees to support human generic drug activities. The current legislative authority expires at the end of September 2027, requiring new legislation for continuation. The meeting aims to gather public views on the proposed recommendations, with comments due by October 17, 2026.

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