FDA GDUFA IV Reauthorization for Fiscal Years 2028-2032
Summary
FDA is preparing for the fourth reauthorization of the Generic Drug User Fee Amendments (GDUFA) covering fiscal years 2028-2032. The current GDUFA III legislative authority, enacted under the FDA User Fee Reauthorization Act of 2022, expires in September 2027, requiring new legislation for FDA to continue collecting generic drug user fees. FDA hosted a public kickoff meeting on July 11, 2025, and has conducted multiple industry and stakeholder discussion sessions documented through March 2026 covering topics including fee structures, ANDA process improvements, facility inspections, and drug master files.
“The current legislative authority for GDUFA III expires in September 2027.”
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What changed
FDA has initiated the reauthorization process for the Generic Drug User Fee Amendments (GDUFA IV) covering fiscal years 2028-2032. The current GDUFA III authorization expires in September 2027, and new legislation will be required for FDA to continue collecting generic drug user fees to fund the review of generic drug applications. FDA held a public kickoff meeting on July 11, 2025, and has been conducting ongoing industry and stakeholder discussions on proposed enhancements including fee structures, ANDA process improvements, cGMP compliance communication tools, facility inspection and classification, drug master files, controlled correspondence, and prioritization mechanisms.
Generic drug manufacturers and pharmaceutical companies involved in ANDA submissions should monitor FDA's GDUFA IV reauthorization developments, as changes to user fee programs could affect regulatory costs, timelines, and program requirements. Stakeholders have opportunities to provide input through FDA's documented discussion sessions and formal consultation processes as the reauthorization advances toward legislative action.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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
Filter by Topic: ANDA Amendments ANDA Meeting Program ANDA Process Background Complex Generics Controlled Correspondence Current Good Manufacturing Practice (cGMP) Compliance Communication Tools Data Fidelity Drug Master File (DMF) Early Facility Inspection for US Facilities Extending Goal Dates after pOAI Alerts Facility Inspection and Classification Filing Language Filing Language Fix Finance Finance (Small Group Meeting) Foreign Fee Differential Forfeiture Determinations and Timelines Ground rules Inactive Ingredient Database Maximum Daily Dosage Online Database of ANDA and DMF Review Status Postmarketing Commitments Pre-Launch Activities Import Requests (PLAIR) Process Prioritization MAPP Program Fee Proposals REMS Scope Stakeholder Feedback Standardize Information in ANDA Submissions UFA Standardization User Fee Invoice Timing Waive Fees for New Domestic Manufacturers
Clear Filters
| Date | Topics |
|---|---|
| 3/27/2026 | Finance; CGMP Compliance Communication Tools; Commitment Letter Approach |
| 3/26/2026 | Structured Review; Data Fidelity; Controlled Correspondence; Early Facility Inspections for US Facilities; Post PAI Meetings; Finance; ANDA Meeting Program |
| 3/20/2026 | Finance (Small Group Meeting) |
| 3/20/2026 | CGMP Compliance Communication Tools; Structured Review; Facility Inspection and Classification; Data Fidelity |
| 3/18/2026 | Stakeholder Feedback; Structured Review; Forfeiture Determinations; Data Fidelity; Early Facility Inspection for US Facilities; Drug Master Files (DMF); Facility Inspection and Classification; Standard Information in ANDA Submissions |
| 3/13/2026 | Current Good Manufacturing Practice (cGMP) Compliance Communication Tools; Facility Inspection and Classification; Drug Master File (DMF) |
| 3/11/2026 | Prioritization MAPP; REMS; Controlled Correspondence; ANDA Meeting Program; Structured Review; Drug Master Files (DMF) |
| 3/06/2026 | Prioritization MAPP; Maximin Daily Dosing (MDD); Forfeiture Determinations; ANDA Meeting Program; Additional Topics |
| 3/04/2026 | Maximum Daily Dosage; Inactive Ingredient Database; Structured Review; Drug Master Files (DMF), Pre-Launch Activities Importation Requests (PLAIR) Process; ANDA Meeting Program; Controlled Correspondence |
| 2/19/2026 | Drug Master Files (DMF); Structured Review; Standardized Information for ANDA Submission; Postmarketing Commitments; Forfeiture Determinations and Timelines |
| 2/19/2026 | Finance (Small Group Meeting) |
| 2/11/2026 | Finance (Small Group Meeting) |
| 2/11/2026 | Prioritization MAPP; REMS; Controlled Correspondence; Extending Goal Dates after pOAI Alerts; Facility Inspection and Classification; Data Fidelity; Current Good Manufacturing Practice (cGMP) Compliance Communication Tools |
| 2/04/2026 | Prioritization MAPP; ANDA Meeting Program; Controlled Correspondence |
| 2/04/2026 | Finance (Small Group Meeting) |
| 1/28/2026 | Maximum Daily Dosage; Inactive Ingredient Database; Filing Language Fix; Finance |
| 1/21/2026 | User Fee Invoice Timing; Prioritization MAPP; Waive Fees for New Domestic Manufacturers; Foreign Fee Differential; Early Facility Inspection for US Facilities |
| 1/21/2026 | Finance (Small Group Meeting) |
| 1/14/2026 | Finance (Small Group Meeting) |
| 1/14/2026 | Forfeiture Determinations and Timelines; Pre-Launch Activities Import Requests (PLAIR) Process; Postmarketing Commitments; Stakeholder Feedback |
| 1/07/2026 | Waive Fees for New Domestic Manufacturers; Foreign Fee Differential; Prioritization MAPP; Data Fidelity |
| 12/17/2025 | User Fee Invoice Timing; Fee Allocation Percentages; Program Fee |
| 12/10/2025 | Drug Master File (DMF); Current Good Manufacturing Practice (cGMP) Compliance Communication Tools; Standardize Information in ANDA Submissions |
| 11/19/2025 | Inactive Ingredient Database; Extending Goal Dates after pOAI Alerts; Facility Inspection and Classification; Early Facility Inspection for US Facilities |
| 11/12/2025 | UFA Standardization; Filing Language; Online Database of ANDA and DMF Review Status; ANDA Amendments |
| 11/06/2025 | Scope; Inactive Ingredient Database; Maximum Daily Dosage; ANDA Meeting Program |
| 12/04/2025 | ANDA Process; Complex Generics; Controlled Correspondence |
| 10/22/2025 | Ground rules; Background; Scope; Proposals |
Stakeholder Discussions on Reauthorization
| Date | Topics |
|---|---|
| 3/10/2026 | Follow-up from Negotiation Meeting Minutes and Previous Topics |
| 2/10/2026 | DMF Assessment; Additional Enhancements |
| 1/13/2026 | ANDA Development; Complex Generics |
| 12/09/2025 | Facilities and Inspections; User Fee Management and Fee Structure |
| 11/10/2025 | ANDA Review; Performance Reporting |
| 10/14/2025 | Scope; Background |
- ## Content current as of:
04/24/2026
Regulated Product(s)
- Drugs
- Generic Drugs
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