💊FDA Announces User Fee Rates for Generic Drugs FY 2026
Generic Drug User Fee Rates for Fiscal Year 2026
Summary
The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2026 rates for GDUFA III fees.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
This document outlines the new fee structure for generic drug applications and related facilities, which will significantly impact manufacturers and stakeholders in the pharmaceutical industry. Compliance with these fees beginning October 1, 2025, is essential for operations.