FDA 483 - Rogerio Lobo

An FDA inspection of Rogerio A. Lobo, M.D. at Columbia University Medical Center in New York revealed significant deficiencies in sponsor oversight of an investigational new drug (IND) study. The firm failed to submit annual reports, adequately monitor clinical investigators, ensure investigator qualifications, and maintain control over the investigational drug. These failures led to issues with adverse event reporting and overall study compliance.