{"abstract":"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 This guidance finalizes the revised draft guidance of the same title issued on October 12, 2017, and announces the availability of the technical specifications document entitled \"REMS Document Technical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.\"","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2023/01/05/2022-28602.html","cfr_references":[],"citation":"88 FR 871","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on January 5, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2009-D-0461"],"dockets":[{"supporting_documents":[{"title":"See FDA-2009-D-0461-0026","document_id":"FDA-2009-D-0461-0015"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-01-05","updated_at":"2023-02-24T18:04:56.507-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2009-D-0461-0100","allow_late_comments":null,"id":"FDA-2009-D-0461-0100","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2009-D-0461","title":"Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications"}],"document_number":"2022-28602","effective_on":null,"end_page":873,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/01/05/2022-28602.xml","html_url":"https://www.federalregister.gov/documents/2023/01/05/2022-28602/format-and-content-of-a-risk-evaluation-and-mitigation-strategy-document-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-28602?publication_date=2023-01-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-01-05/2022-28602/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1250,"last_updated":"2026-08-26 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-01-05/pdf/2022-28602.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-28602.pdf?1672839920","publication_date":"2023-01-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/01/05/2022-28602.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"See FDA-2009-D-0461-0026","document_id":"FDA-2009-D-0461-0015"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2009-D-0461","supporting_documents_count":1,"docket_id":"FDA-2009-D-0461","document_id":"FDA-2009-D-0461-0100","regulation_id_number":null,"title":"Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications","checked_regulationsdotgov_at":"2023-02-24T23:04:55Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":871,"subtype":null,"title":"Format and Content of a Risk Evaluation and Mitigation Strategy Document; Guidance for Industry; Availability","toc_doc":"Format and Content of a Risk Evaluation and Mitigation Strategy Document","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}