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) 2027 rates for GDUFA III fees.
US Federal Register - FDA Notices · July 30, 2026
Generic Drug User Fee Rates for Fiscal Year 2027
FDA announces fiscal year 2027 fee rates for generic drug applications, facilities, and applicant programs under GDUFA III.
Published by US Federal Register - FDA Notices. HealthSignal links to the original document; the summary above is extracted from the source text.