Food and drug administration approval process for dermatology drugs in the United States
Food and drug administration approval process for dermatology drugs in the United States
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DOI：
10.1080/09546634.2018.1425361
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发表时间：
2018-01-01
影响因子：
2.9
通讯作者：
Kwatra, Shawn G.
中科院分区：
文献类型：
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作者：
Boozalis, Emily;Semenov, Yevgeniy R.;Kwatra, Shawn G.
目的：本综述的目的是阐明FDA批准新的皮肤病药物的步骤。方法：为了帮助说明药物批准的过程，我们以最近批准的dupilumab （REGN668; Regeneron Pharmaceuticals）为例。结果：一般来说，新的皮肤病药物在接受美国食品和药物管理局（FDA）的审查之前，必须经过非人类受试者的临床前研究和三个阶段的人体临床试验。这一审查过程包括一个跨学科的科学家团队，他们根据药物的疗效、风险效益比和标签能力来决定药物是否应该上市。FDA药物评估和研究中心（CDER）内专门审查皮肤病药物的团队是皮肤病和牙科药物产品部。结论：在药物开发的各个阶段，临床医生的投入促进了药物开发的进程。
Aim: The purpose of this review is to elucidate the steps involved in the FDA's approval of new dermatology drugs.Methods: To help illustrate the process of drug approval, we use examples from the recent approval of dupilumab (REGN668; Regeneron Pharmaceuticals).Results: In general, new dermatology drugs must undergo pre-clinical studies on non-human subjects and three phases of clinical trials in humans before undergoing review by the Food and Drug Administration (FDA). This review process involves an interdisciplinary team of scientists that determines if the drug should be brought to market based on its efficacy, risk-to-benefit ratio, and ability to be labeled. The team that specifically reviews dermatology drugs within the Center for Drug Evaluation and Research (CDER) at the FDA is the Division of Dermatologic and Dental Drug Products.Conclusions: The drug development process is enhanced by clinician input during all stages of development.