2025-14411NoticeWallet

Generic Drug Makers Brace for FDA's 2026 Fee Changes

Published Date: 7/30/2025

Notice

Summary

Starting in fiscal year 2026, companies making generic drugs will see updated fees they need to pay to the FDA. These fees affect drug applications, manufacturing sites, and related programs, helping the FDA keep generic medicines safe and available. The new rates kick in soon, so businesses should get ready to budget for these changes.

No Economic Impacts Identified for this Document

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Key Dates

Published Date
Effective Date
7/30/2025
10/1/2025

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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