Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs.
Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs.
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DOI：
10.1016/j.jacbts.2016.03.002
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发表时间：
2016-04
期刊：
影响因子：
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通讯作者：
Van Norman GA
中科院分区：
文献类型：
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作者：
Van Norman GA
在过去的150年里，美国食品和药物管理局(FDA)已经从美国专利局的一个小部门发展成为世界上最大的消费者保护机构之一。它的任务包括确保新的治疗方法尽快到达公众手中，同时确保新的治疗方法既安全又有效。面对消费者的迫切需求，FDA面临着批评，称其过程过于漫长和昂贵，而且美国新药发布的时间比其他西方国家长得多。公众要求放松FDA监管，以促进药品和器械更快获得批准的呼声，被一些批准的药物上市后发生的患者伤害和死亡事件所反击。在美国，新药和设备从临床前测试到批准平均分别需要12年和7年的时间。医疗器械的研发成本高达数百万美元，最近的一项研究表明，一种新药的全部成本超过10亿美元。对于寻求新药和设备批准的调查人员来说，FDA的过程可能是艰巨的。这个由两部分组成的系列旨在概述通过FDA流程带来新药和设备所涉及的步骤。第1部分涉及新药审批程序。第2部分继续介绍对医疗器械的批准。
Over the last 150 years, the U.S. Food and Drug Administration (FDA) has evolved from a small division of the U.S. Patent Office to 1 of the largest consumer protection agencies in the world. Its mission includes ensuring that new medical treatments reach the public as quickly as possible while simultaneously ensuring that new treatments are both safe and effective. In the face of urgent consumer need, the FDA has faced criticism that its processes are too lengthy and costly and that the time to new drug release is significantly longer in the United States than in other Western countries. Calls from the public to loosen FDA regulations to facilitate more rapid approval of drugs and devices have been countered by the occurrence of patient harm and deaths after some approved drugs have reached the marketplace. New drug and device approval in the United States take an average of 12 and 7 years, respectively, from pre-clinical testing to approval. Costs for development of medical devices run into millions of dollars, and a recent study suggests that the entire cost for a new drug is in excess of $1 billion. For investigators seeking approval for new drugs and devices, FDA processes can be formidable. This 2-part series is intended to provide an overview of the steps involved in bringing new drugs and devices through the FDA process. Part 1 concerns the process of new drug approvals. Part 2 continues with approval of medical devices.