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 safety requirements.

FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.    
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