美国皮肤科药物的食品药品监督管理局批准流程。

Food and drug administration approval process for dermatology drugs in the United States.

作者信息

Boozalis Emily, Semenov Yevgeniy R, Kwatra Shawn G

机构信息

a Department of Dermatology , Johns Hopkins University School of Medicine , Baltimore , MD , USA.

b Division of Dermatology , Washington University School of Medicine , St. Louis , MO , USA.

出版信息

J Dermatolog Treat. 2018 Sep;29(6):536-538. doi: 10.1080/09546634.2018.1425361. Epub 2018 Jan 26.

DOI:10.1080/09546634.2018.1425361

PMID:29304565

Abstract

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.

摘要

目的

本综述的目的是阐明美国食品药品监督管理局（FDA）批准新皮肤科药物所涉及的步骤。

方法

为帮助说明药物批准过程，我们采用了度普利尤单抗（REGN668；再生元制药公司）近期获批的例子。

结果

一般而言，新的皮肤科药物在接受美国食品药品监督管理局（FDA）审查之前，必须先在非人类受试者身上进行临床前研究，并在人体中进行三个阶段的临床试验。这一审查过程涉及一个跨学科的科学家团队，该团队根据药物的疗效、风险效益比和标注能力来决定是否应将其推向市场。FDA药品评价和研究中心（CDER）内专门审查皮肤科药物的团队是皮肤和牙科药品部。