A draft guidance describing the format and content of a proposed risk evaluation and mitigation strategy (REMS) was published by the FDA. Titled "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications," the draft guidance also includes: (1) the format and content of a proposed risk evaluation and mitigation strategy, including supporting documentation; (2 ) the content of assessments and proposed modifications of approved REMS; (3) identifiers to use on REMS documents, (4) and methods of communication with the FDA about a REMS.
SOURCE: FDA Notice
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