Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistDr. Ralph A. DeFronzo at the University of Texas Health Science Center at San Antonio failed to conduct investigational drug studies in accordance with FDA regulations during inspections of two clinical protocols conducted between December 3-6, 2024. The primary violation cited was failure to ensure clinical investigations were conducted according to the investigational plan, specifically regarding subject eligibility criteria requirements under 21 CFR 312.60. The inspection was part of the FDA's Bioresearch Monitoring Program, which focuses on protecting human subjects' rights, safety, and welfare in clinical research.