federal_register: 2018-26285

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2018-26285 Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants 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 "Post- Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA." This guidance is intended to clarify the criteria for granting post-complete response letter (CRL) meeting requests and the scope of discussions for granted meeting requests. This guidance provides procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years 2018-2022 (GDUFA II). 2018-12-04 2018 12 https://www.federalregister.gov/documents/2018/12/04/2018-26285/post-complete-response-letter-meetings-between-the-food-and-drug-administration-and-abbreviated-new https://www.govinfo.gov/content/pkg/FR-2018-12-04/pdf/2018-26285.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 "Post- Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA." This guidance is intended to clarify the...

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