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  1. Generic Drug User Fee Amendments

GDUFA IV: Fiscal Years 2028 – 2032

In September 2022, the FDA User Fee Reauthorization Act of 2022 (FDAUFRA) was enacted, which included the third reauthorization of the Generic Drug User Fee Amendments (GDUFA). The current legislative authority for GDUFA III expires in September 2027. At that time, new legislation will be required for FDA to continue collecting generic drug user fees in future fiscal years to fund the process for the review of generic drug product applications.

Information related to FDA’s preparation for the fourth reauthorization of GDUFA will be hosted on this page as it becomes available.

GDUFA IV Reauthorization Kickoff Public Meeting - July 11, 2025

FDA hosted a public meeting on July 11, 2025 to kick off the process for reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 through 2032.

Industry and Stakeholder Discussions on Reauthorization

FDA will develop proposed enhancements for GDUFA IV in consultation with drug industry representatives, patient and consumer advocates, health care professionals, and other public stakeholders. The notes from FDA’s discussions with industry and other stakeholders will be posted on this page as they become available.

Industry Discussions on Reauthorization

DateTopics
01/7/2026Waive Fees for New Domestic Manufacturers; Foreign Fee Differential; Prioritization MAPP; Data Fidelity
12/17/2025User Fee Invoice Timing; Fee Allocation Percentages; Program Fee
12/10/2025Drug Master File (DMF); Current Good Manufacturing Practice (cGMP) Compliance Communication Tools; Standardize Information in ANDA Submissions
11/19/2025Inactive Ingredient Database; Extending Goal Dates after pOAI Alerts; Facility Inspection and Classification; Early Facility Inspection for US Facilities
11/12/2025UFA Standardization; Filing Language; Online Database of ANDA and DMF Review Status; ANDA Amendments 
11/6/2025Scope; Inactive Ingredient Database; Maximum Daily Dosage; ANDA Meeting Program
12/4/2025ANDA Process; Complex Generics; Controlled Correspondence
10/22/2025Ground rules; Background; Scope; Proposals

Stakeholder Discussions on Reauthorization

DateTopics
12/9/2025Facilities and Inspections; User Fee Management and Fee Structure
11/10/2025ANDA Review; Performance Reporting
10/14/2025Scope; Background
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