federal_register: 2022-01605

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2022-01605 Information Requests and Discipline Review Letters Under Generic Drug User Fee Amendments; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Information Requests and Discipline Review Letters Under GDUFA." This guidance explains how FDA will issue and use an information request (IR) and/or a discipline review letter (DRL) during the assessment of an original abbreviated new drug application (ANDA) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This guidance finalizes the draft guidance of the same title issued on December 18, 2017. 2022-01-27 2022 1 https://www.federalregister.gov/documents/2022/01/27/2022-01605/information-requests-and-discipline-review-letters-under-generic-drug-user-fee-amendments-guidance https://www.govinfo.gov/content/pkg/FR-2022-01-27/pdf/2022-01605.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Information Requests and Discipline Review Letters Under GDUFA." This guidance explains how FDA will issue and use an information...  

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