Document Type
Article
Publication Date
May 2007
Abstract
Products approved by the US Food and Drug Administration (FDA) for one use are often put to other uses. This practice, known colloquially as "off-label usage," is neither illegal nor unethical. Physicians can and should pursue scientifically sound use supported by medical evidence. The FDA requires only that we:
--Be well informed about the product
--Base its use on firm scientific rationale and sound medical evidence, if available
--Maintain records of the product’s use and effects
--Carry out good medical practice
--Use good judgment
--Consider the best interests of the patient before all else
Recommended Citation
Reiter, David MD, "Sailing the straits of approval: The nature of FDA approval and its implications for surgeons" (2007). Department of Otolaryngology - Head and Neck Surgery Faculty Papers. Paper 2.
https://jdc.jefferson.edu/otofp/2
Comments
This article has been peer reviewed. It is the author's final version prior to publication in Facial Plastic Surgery Clinics of North America 15(2):247-250, 2007. The published version is available at http://dx.doi.org/10.1016/j.fsc.2007.01.009. Copyright © 2007 Elsevier, Inc.