federal_register: 2017-12836

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2017-12836 Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Associated with Priority Submissions; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions." The Pre-Submission Facility Correspondence (PFC) process was identified as part of the performance goals and program enhancements for the Generic Drug User Fee Amendments reauthorization for Fiscal Years 2018-2022 (GDUFA II). A complete and accurate PFC allows the Agency to begin the facility assessment process in advance of the planned abbreviated new drug application (ANDA) submission. This draft guidance describes PFC content and format, as well as the Agency's approach to assessing this information. 2017-06-20 2017 6 https://www.federalregister.gov/documents/2017/06/20/2017-12836/abbreviated-new-drug-applications-pre-submission-facility-correspondence-associated-with-priority https://www.govinfo.gov/content/pkg/FR-2017-06-20/pdf/2017-12836.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and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions." The Pre-Submission Facility Correspondence...  

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