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Updated: Aug 21, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Trials and tribulations: a primer on successfully navigating the waters of the Food and Drug Administration
Matt Feinsod1, Wiley A Chambers
1United States Food and Drug Administration, Rockville, Maryland 20850, USA.
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.
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