美国食品和药物管理局在皮肤科药物开发中的作用。

The Food and Drug Administration's Role in Dermatologic Drug Development.

机构信息

Division of Dermatology and Dentistry, Office of Inflammation and Immunology, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, WO22, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA.

出版信息

Dermatol Clin. 2022 Jul;40(3):249-263. doi: 10.1016/j.det.2022.02.001.

DOI:10.1016/j.det.2022.02.001

PMID:35750409

Abstract

The mission of the Food and Drug Administration (FDA) is to ensure the safety and effectiveness of dermatologic drugs, as authorized by the Federal Food, Drug, and Cosmetic Act (FD&CA). In this article, we discuss how the FDA's policies and practices have continued to evolve to incorporate scientific advances and to facilitate approval for dermatologic drugs in a timely manner for a broad spectrum of patients. We provide several examples to highlight areas where the Division of Dermatology and Dentistry found common ground with stakeholders to increase the therapeutic options for dermatologic patients, while still maintaining regulatory standards required for approval.

摘要

美国食品药品监督管理局（FDA）的使命是根据《联邦食品、药品和化妆品法案》（FD&C 法案），确保皮肤科药物的安全性和有效性。本文讨论了 FDA 的政策和实践如何不断发展，以纳入科学进步，并及时为广泛的患者批准皮肤科药物。我们提供了几个例子，重点介绍了皮肤科和牙科司与利益相关者找到共同点的领域，以增加皮肤科患者的治疗选择，同时仍保持批准所需的监管标准。