Generic Drug User Fee Rates for Fiscal Year 2027
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.
Read the official notice →Source: Federal Register (FDA/USDA food labeling) · US Government work (public domain). This is a short, attributed summary; the full authoritative text lives on the authority’s own site. LabelYog does not author or endorse it — confirm compliance against the destination market’s official source.
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What this means for your label
A notice like this changes what a pack must carry. These are the rules we build against, starting with US FDA.