WASHINGTON, July 30 -- Food and Drug Administration has issued a notice called: Generic Drug User Fee Rates for Fiscal Year 2026.
The notice was published in the Federal Register on July 30 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
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) facilit...