Research Deviations in FDA-Regulated Clinical Trials: A Cross-Sectional Analysis of FDA Inspection Citations

Garmendia, CA; Epnere, K; Bhansali, N

Garmendia, CA (reprint author), US FDA, 15100 NW 67th Ave,Suite 400, Miami Lakes, FL 33014 USA.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2018; 52 (5): 579

Abstract

Background: The US Food and Drug Administration (FDA) ensures clinical trials meet regulatory/ethical standards through inspections. If FDA Investigat......

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