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Director's Forum Understanding the Food and Drug Administration Risk Evaluation and Mitigation Strategies (REMS)

机译:主任论坛了解食品和药物管理局的风险评估和缓解策略(REMS)

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摘要

The Director's Forum series is written and edited by Robert "Weber and Scott Mark and is designed to guide pharmacy leaders in establishing patient-centered services in hospitals and health systems. As the Food and Drug Administration (FDA) approval process becomes more stringent with regard to postmarketing surveillance for medications, directors of pharmacy will need to understand expectations of inpatient pharmacy services to ensure patient safety and meet requirements. This article provides background information regarding the FDA Risk Evaluation and Mitigation Strategies (REMS) programs and potential implications for hospital pharmacy.
机译:董事论坛系列由罗伯特·韦伯和斯科特·马克撰写和编辑,旨在指导药房负责人在医院和卫生系统中建立以患者为中心的服务。随着食品药品监督管理局(FDA)的批准程序变得更加严格在药品上市后监督方面,药房主管需要了解对住院药房服务的期望,以确保患者安全并符合要求,本文提供了有关FDA风险评估和缓解策略(REMS)计划的背景信息以及对医院药房的潜在影响。

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