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Practice Tip: FDA Issues Draft Guidance for REMS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this article discussed the background of REMS (Risk Evaluation and Mitigation Strategies) and provided a summary of the Draft Guidance.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.

20 minute read March 30, 2010 at 10:26 AM
By
Alan Minsk
Practice Tip: FDA Issues Draft Guidance for REMS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this article discussed the background of REMS (Risk Evaluation and Mitigation Strategies) and provided a summary of the Draft Guidance, including the content and format of a proposed REMS submission.

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