Risk Evaluation and Mitigation Strategies (REMS) Compliance Program
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- Опубликовано: 11 июл 2024
- 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.
Learn more at: www.fda.gov/drugs/news-events...
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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