Hyman Paul M, Carvajal Ricardo
Hyman, Phelps & McNamara, P.C., Washington, DC 20005-5929, USA.
Dermatol Ther. 2009 May-Jun;22(3):216-24. doi: 10.1111/j.1529-8019.2009.01234.x.
Dermatologists have at their disposal a wide range of products to recommend or prescribe to their patients, all of which are regulated in some way by the Food and Drug Administration (FDA). However, the degree to which FDA has confirmed the safety and efficacy of a dermatological product can vary widely. Most prescription and some over-the-counter drugs and medical devices are approved by the FDA based on scientific data. Most over-the-counter drugs are marketed in compliance with FDA regulations based on expert medical review. The FDA clears most medical devices based on their substantial equivalence to other legally marketed devices. Cosmetics, medical foods, and dietary supplements are subject only to general postmarket prohibitions against adulterated and misbranded products, although the FDA may review ingredient safety and specific claims for dietary supplements. Some product information is available on FDA's Web site, but the prudent physician should supplement that information by reviewing available scientific literature.
皮肤科医生有多种产品可供推荐或开给患者,所有这些产品都在某种程度上受到美国食品药品监督管理局(FDA)的监管。然而,FDA确认皮肤科产品安全性和有效性的程度差异很大。大多数处方药以及一些非处方药和医疗器械是基于科学数据获得FDA批准的。大多数非处方药是根据专家医学审查,按照FDA规定进行销售的。FDA根据大多数医疗器械与其他合法上市器械的实质等同性对其进行批准。化妆品、医用食品和膳食补充剂仅受上市后对掺假和标签错误产品的一般禁令约束,不过FDA可能会审查膳食补充剂的成分安全性和特定声明。FDA网站上可获取一些产品信息,但谨慎的医生应通过查阅现有科学文献来补充这些信息。