Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistBased on limited metadata, this Warning Letter was issued to Joseph A. Zadra, M.D., a clinical investigator, by the FDA's Center for Drug Evaluation and Research (CDER) in October 2021. The violations appear to relate to investigator conduct and responsibilities in clinical drug trials, though specific details are not available from the metadata alone. As a clinical investigator warning, this likely concerns compliance with regulations governing the conduct of human subjects research under IND (Investigational New Drug) applications. The letter's scope falls under CDER's oversight of drug development and clinical investigation standards.