federal_register: 2017-27124

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2017-27124 Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Information Requests and Discipline Review Letters Under GDUFA." This draft guidance explains how FDA will issue and use an information request (IR) and/or a discipline review letter (DRL) during the review of an original abbreviated new drug application (ANDA). 2017-12-18 2017 12 https://www.federalregister.gov/documents/2017/12/18/2017-27124/information-requests-and-discipline-review-letters-under-the-generic-drug-user-fee-amendments-draft https://www.govinfo.gov/content/pkg/FR-2017-12-18/pdf/2017-27124.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and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Information Requests and Discipline Review Letters Under GDUFA." This draft guidance explains how FDA will issue and use an...

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