federal_register: 2019-05760

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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
2019-05760 Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Guidance for Industry." The guidance document provides the recommendations of the Center for Biologics Evaluation and Research (CBER) on the use of standards in product development and control as well as the use of such standards in CBER's managed review process. CBER recognizes the value of standards and encourages the use of appropriate standards in the development and control of CBER-regulated medical products. Sponsors' use of standards can facilitate product development and provide a more efficient evaluation of regulatory submissions. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2017. 2019-03-26 2019 3 https://www.federalregister.gov/documents/2019/03/26/2019-05760/standards-development-and-the-use-of-standards-in-regulatory-submissions-reviewed-in-the-center-for https://www.govinfo.gov/content/pkg/FR-2019-03-26/pdf/2019-05760.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 entitled "Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research;...  

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