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REMSadvisor.com | An Information Resource Site for FDA REMS
An Information Resource Site for FDA REMS. Insights and Strategies for a Successful REMS Assessment – Part 1. Part 1: Overview and Assessment Design Since March 2008, the U.S. FDA has taken action on its new authority under. FDA’s Draft Risk Evaluation and Mitigation Strategy (REMS) Guidance A Preliminary Review (Part II). FDA’s Draft Risk Evaluation and Mitigation Strategy (REMS) Guidance A Preliminary Review (Part I). REMS Performance Assessments - The Common Element to REMS. August 18, 2010.
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