2022-28602: Format and Content of a Risk Evaluation and Mitigation Strategy Document; Guidance for Industry; Availability
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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 This guidance finalizes the revised draft guidance of the same title issued on October 12, 2017, and announces the availability of the technical specifications document entitled "REMS Document Technical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."
The agency’s own summary, as published.
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