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# User Fee Rates Set for FY 2026
- URL: https://www.fdaweb.com/user-fee-rates-set-for-fy-2026/
- Published: 2025-07-29T12:00:00.000Z
- Updated: 2026-09-14T15:17:41.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5159591

FDA has posted the following user fee rates for fiscal year 2026 (effective 10/1). They are:

- [Prescription drugs and biologics: ](https://substack.com/redirect/994191b9-f2fc-4d2b-9416-4ac331bdec30?j=eyJ1IjoiNGVsYmcifQ.ZBLBbEt110YXyNPzL-ezgpiD2Jz%5FF4WsjEIF4Q2V0g0&ref=fdaweb.com) $4.682 million for an application requiring clinical data. This is an 8.6% increase in the current fee. The annual program fee is $442,213, which is a 9.5% decrease.
- [Biosimilars: ](https://substack.com/redirect/12c66294-8911-465f-90ec-04c865df21e7?j=eyJ1IjoiNGVsYmcifQ.ZBLBbEt110YXyNPzL-ezgpiD2Jz%5FF4WsjEIF4Q2V0g0&ref=fdaweb.com) $1.201 million for an application requiring clinical data, which is an 18.3% decrease in the current fee
- [Medical devices:](https://substack.com/redirect/914ab7a9-dc0c-4e2f-b825-1abebb570409?j=eyJ1IjoiNGVsYmcifQ.ZBLBbEt110YXyNPzL-ezgpiD2Jz%5FF4WsjEIF4Q2V0g0&ref=fdaweb.com) $540,783 for a PMA application, which is a 7/1% increase over the current fee. The fee for a 510(k) is $24,335.
- [Generic drugs:](https://substack.com/redirect/ac7e3494-4e1c-48b5-ac44-50939a1c6037?j=eyJ1IjoiNGVsYmcifQ.ZBLBbEt110YXyNPzL-ezgpiD2Jz%5FF4WsjEIF4Q2V0g0&ref=fdaweb.com) $358,247 for an ANDA submission, which is an 11.3% increase in the current fee.

The links above are to the corresponding *Federal Register* notices detailing the fee structure for each program.