Trials and tribulations: A primer on successfully navigating the waters of the Food and Drug Administration☆
Received 5 December 2003; accepted 19 May 2004.
Abstract
Conducting clinical trials in a regulated environment constitutes unfamiliar territory for most physicians. There exists no formal training in this subject, so many clinicians lack even a basic understanding of the procedures required by the Federal Food, Drug, and Cosmetic Act and their implications vis-à-vis clinical practice. The authors distill drug regulation to relevant applications and elucidate the rationale and procedures for submitting an Investigational New Drug application by providing a user-friendly road map of the process.
1United States Food and Drug Administration, Rockville, Maryland, USA
Correspondence to Wiley Chambers, MD, Division of Antiinflammatory, Analgesic, and Ophthalmic Drug Products, FDA, 9201 Corporate Boulevard, HFD-550, Rockville, MD 20850, USA.
The opinions and assertions expressed in this article are the private views of the authors. No endorsement by the Food and Drug Administration is intended or should be inferred.
ABSTRACT