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57:37
YouTube
U.S. Food and Drug Administration
Risk Evaluation and Mitigation Strategies (REMS) Compliance Program
Haley Seymour from CDER’s Division of Enforcement and Postmarketing Safety (DEPS) providess an overview of the REMS Compliance Program. The REMS Compliance team develops risk-based enforcement and communication strategies that ensure that drugs approved have reliable evidence of safety and effectiveness by ensuring that they meet post-market ...
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