Federal Register :: Generic Drug User Fee Rates for Fiscal Year 2020

The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files…
— Read on www.federalregister.gov/documents/2019/07/26/2019-15906/generic-drug-user-fee-rates-for-fiscal-year-2020

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