federal_register: 2017-15654

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2017-15654 Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self- Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance." The Generic Drug User Fee Amendments of 2012 (GDUFA) are designed to speed the delivery of safe and effective generic drugs to the public and to improve the review process for abbreviated new drug applications (ANDAs). This guidance is intended to provide 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 the requirements and commitments of GDUFA. This guidance finalizes the draft guidance originally issued in August 2012 and issued in revised draft form in September 2013. 2017-07-26 2017 7 https://www.federalregister.gov/documents/2017/07/26/2017-15654/generic-drug-user-fee-amendments-of-2012-questions-and-answers-related-to-self-identification-of https://www.govinfo.gov/content/pkg/FR-2017-07-26/pdf/2017-15654.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 the guidance entitled "Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self- Identification of Facilities, Review of Generic Drug Submissions,...  

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