Federal Register #FDA-2026-N-3273

FDA Public Meeting on Financial Transparency and Efficiency of Drug User Fee Acts

This notice announces a public meeting hosted by the Food and Drug Administration (FDA) to discuss financial transparency and efficiency related to the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Generic Drug User Fee Amendments (GDUFA). - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors: - FDA (as the host and organizer) - Products/Services Requested: - No products or services are being procured or awarded - The notice requests public comments and participation in the meeting - Unique or Notable Requirements: - Focus on financial transparency, five-year financial plans, resource capacity planning, and modernized time reporting for drug user fee programs - Hybrid meeting format: both virtual and in-person attendance options - In-person location at FDA White Oak Campus, Great Room, Section A - Public input is encouraged; no procurement action is involved

Description

The Food and Drug Administration (FDA) is announcing a public meeting to discuss the financial transparency and efficiency of the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Generic Drug User Fee Amendments (GDUFA). The meeting will cover FDA's five-year financial plans for these programs and progress in resource capacity planning and modernized time reporting. The event will be held as a hybrid meeting with virtual and in-person attendance options, and comments are requested by July 23, 2026.

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