Trials and tribulations: a primer on successfully navigating the waters of the Food and Drug Administration.
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.
Feinsod
Matt
M
United States Food and Drug Administration, Rockville, Maryland 20850, USA.
Chambers
Wiley A
WA
D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D006801:Humans; D017387:Investigational New Drug Application / Q000379:methods / Q000458:organization & administration*; D009885:Ophthalmology / Q000458:organization & administration*; D004364:Pharmaceutical Preparations; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000458:organization & administration*
D004364:Pharmaceutical Preparations