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.
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Previous: 2025-14410, Outsourcing Facility Fee Rates for Fiscal Year 2026
If you run a drug-compounding outsourcing facility, the FDA just set the fees for fiscal year 2026. Small businesses will pay $6,829, while bigger ones owe $20,726, plus $20,486 for any reinspections. These fees help keep drug safety in check, so get ready to pay on time and keep your facility in tip-top shape!
Next: 2025-14412, Medical Device User Fee Rates for Fiscal Year 2026
The FDA is setting new fees for medical device companies for the year starting October 1, 2025. These fees cover things like device submissions and annual registrations, with some discounts for small businesses. If you’re in the medical device world, get ready to pay updated fees and follow new payment rules in FY 2026.