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  1. Developing Products for Rare Diseases & Conditions

Director for the Office of Orphan Products Development

Ilan Irony, M.D. is the Acting Director for the Office of Orphan Products Development (OOPD). Dr. Irony received clinical research training at the University of California, San Francisco (UCSF) and Internal Medicine training at Georgetown University Hospital. Prior to joining FDA, Dr. Irony worked in endocrine-related clinical research at the National Institutes of Health (NIH) and in private medical practice specializing in Internal Medicine and Endocrinology. Dr. Irony joined the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) in 2000 as a clinical reviewer. He also worked in the Endocrine Division within the Center for Drug Evaluation and Research (CDER) as a reviewer and team leader. In 2011, he returned to CBER as the branch chief, and in 2017 became Deputy Director in the Division of Clinical Evaluation and Pharmacology / Toxicology in the Office of Tissues and Advanced Therapies. Over the course of his career at FDA, Dr. Irony has reviewed many applications intended for treatment of rare disorders, has presented on development of orphan products and participated in activities with rare disease organizations.