使用美国食品药品监督管理局批准的药物用于未标明的（标签外）用途。法律和伦理方面的影响。
The use of Food and Drug Administration--approved medications for unlabeled (off-label) uses. The legal and ethical implications.
作者信息
Torres A
机构信息
Department of Dermatology and Health Administration, Loma Linda University School of Medicine, Calif.
出版信息
Arch Dermatol. 1994 Jan;130(1):32-6.
PMID:8285737
Abstract
Physicians increasingly use Food and Drug Administration (FDA)-approved drugs (medication) for unlabeled (off-label) indications. The ethical and legal implications of these actions are not always clear. In this article, I examine the common law and federal statutory regulations concerning this issue and also explore some of the ethical and financial issues involved.
摘要
医生越来越多地将美国食品药品监督管理局（FDA）批准的药物用于未标明的（即所谓“无标签”）适应症。这些行为的伦理和法律影响并不总是清晰明确的。在本文中，我将审视关于此问题的普通法和联邦法规，并探讨其中涉及的一些伦理和财务问题。
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