federal_register: 2017-22050

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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
2017-22050 Format and Content of a Risk Evaluation and Mitigation Strategy Document; Revised Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Format and Content of a REMS Document." A Risk Evaluation and Mitigation Strategy (REMS) document, which is part of a REMS that is required by FDA, establishes the goals and requirements of the REMS. This revised draft guidance describes a new recommended format for a REMS document. The new format was developed based on extensive stakeholder feedback. This guidance revises and supersedes the draft guidance entitled "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications," that was published by FDA on October 1, 2009. 2017-10-12 2017 10 https://www.federalregister.gov/documents/2017/10/12/2017-22050/format-and-content-of-a-risk-evaluation-and-mitigation-strategy-document-revised-draft-guidance-for https://www.govinfo.gov/content/pkg/FR-2017-10-12/pdf/2017-22050.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Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Format and Content of a REMS Document." A Risk Evaluation and Mitigation Strategy (REMS) document, which is part of a...  

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