Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistTyrone L. McCall, M.D. and Cornea Associates of Texas, operating as a drug sponsor and clinical investigator, failed to submit required Investigational New Drug (IND) applications before conducting clinical investigations with investigational drugs, in violation of 21 CFR 312.20 and 312.40. The FDA's Bioresearch Monitoring Program inspection conducted in September 2022 identified that the sponsor did not adhere to applicable statutory requirements under the Federal Food, Drug, and Cosmetic Act and Title 21 regulations governing the conduct of clinical investigations and protection of human subjects.