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FDA对处方药的监管
FDA Regulation of Prescription Drugs


Audrey L. Gassman ... 其他 • 2017.02.16

2015年,美国零售药店共配出约40亿份处方药1。美国食品药品监督管理局(Food and Drug Administration,FDA)下属的药品评价和研究中心(The Center for Drug Evaluation and Research,CDER)确保处方药品有可靠的质量与纯度,并且对于目标人群而言,处方药品提供的获益高于风险2。FDA本身并不开发药物,也不进行临床试验。制药公司负责这些项目,大学及学术医疗中心也做出重要贡献3。FDA为制药公司提供指南,评估其项目产生的数据,再决定某种药品是否可以获得批准。审批标准为拥有实质证据证明有效性,以及获益高于风险和尚存不确定性因素4。通过审批后,FDA继续通过多种数据源监察药品,包括临床试验、流行病学研究以及药品上市后的报告5。本文目的是帮助开具FDA批准药品处方的医师理解药品监管的要点。我们将重点放在CDER的作用及数据上,不涵盖由FDA其他中心监管的产品。





作者信息

Audrey L. Gassman, M.D., Christine P. Nguyen, M.D., and Hylton V. Joffe, M.D., M.M.Sc.
From the Division of Bone, Reproductive, and Urologic Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD. Address reprint requests to Dr. Joffe at the Division of Bone, Reproductive, and Urologic Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, or at hylton.joffe@fda.hhs.gov.

 

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