The first part of this article discussed the background of REMS (Risk Evaluation and Mitigation Strategies) and provided a summary of the Draft Guidance, including the content and format of
Practice Tip: FDA Issues Draft Guidance for REMS
The first part of this article discussed the background of REMS (Risk Evaluation and Mitigation Strategies) and provided a summary of the Draft Guidance. The conclusion herein explains the second part of the procedure, including proposed modifications and communicating with the FDA.
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