After training at UCSF and NIH and years of practice in Internal Medicine and Endocrinology, Dr. Irony joined FDA CBER in 2000 as a clinical reviewer. He also worked in the Endocrine Division in CDER as a reviewer and team leader. In 2011, he returned to CBER first as branch chief, and then became Deputy Director in the Division of Clinical Evaluation and Pharmacology / Toxicology in the Office of Tissues and Advanced Therapies. In 2018 he was detailed as director of the Office of Orphan Products Development.