federal_register: 2022-28602

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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
2022-28602 Format and Content of a Risk Evaluation and Mitigation Strategy Document; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Format and Content of a REMS Document." This final guidance describes the format for a proposed risk evaluation and mitigation strategy (REMS) document. This format was created based on extensive stakeholder feedback. This guidance finalizes the revised draft guidance of the same title issued on October 12, 2017, and announces the availability of the technical specifications document entitled "REMS Document Technical Conformance Guide." 2023-01-05 2023 1 https://www.federalregister.gov/documents/2023/01/05/2022-28602/format-and-content-of-a-risk-evaluation-and-mitigation-strategy-document-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2023-01-05/pdf/2022-28602.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 "Format and Content of a REMS Document." This final guidance describes the format for a proposed risk evaluation and mitigation...  

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