federal_register: 2016-27761

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2016-27761 Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of guidance for industry entitled "Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments." This guidance provides updated answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding GDUFA user fees and finalizes the revised version of the guidance. 2016-11-18 2016 11 https://www.federalregister.gov/documents/2016/11/18/2016-27761/generic-drug-user-fee-amendments-of-2012-questions-and-answers-related-to-user-fee-assessments https://www.govinfo.gov/content/pkg/FR-2016-11-18/pdf/2016-27761.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 guidance for industry entitled "Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments." This guidance provides updated answers...  

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