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avatar for Stephanie Omokaro

Stephanie Omokaro

FDA
Lead Medical Officer, Office of New Drugs, CDER
Dr. Omokaro is a Lead Medical Officer in the Division of Gastroenterology and Inborn Errors Products in the Center for Drug Evaluation and Research at FDA. She was educated in Biochemistry at Cornell University, and in medicine at Boston University. She completed a pediatric residency at Johns Hopkins Hospital and a fellowship in pediatric hematology/oncology at Johns Hopkins Hospital and the National Institutes of Health. Her medical interests include drug-induced liver injury and immune tolerance induction therapies. Dr. Omokaro has over 9 years of regulatory experience in the review and management of INDs, NDAs, BLAs, and 505(b)(2) applications including complex efficacy, safety and clinical trial design issues.