John Sharretts, MD is an expert in the scientific and regulatory foundations underlying clinical development of new drugs and therapeutic biologics regulated by FDA’s Center for Drug Evaluation and Research (CDER), with a focus on metabolic diseases. He served his entire FDA career in the Office of New Drugs (OND), including as Director of the Division of Diabetes, Lipid Disorders, and Obesity (DDLO) prior to his departure from FDA in 2026.
Dr. Sharretts started at FDA in 2015 as a clinical reviewer and served as a Lead Physician and Deputy Director of DDLO before becoming Director. His knowledge and skillset encompass guidance development, clinical holds, advisory committees, formal dispute resolutions, and other policy considerations such as the use of novel clinical endpoints and biomarkers.
His therapeutic expertise includes obesity, type 1 and type 2 diabetes, hypoglycemic disorders, hypercholesterolemia, and hypertriglyceridemia, and he has been involved in approvals for pediatric and rare disease indications in these therapeutic areas. Additionally, he has extensive experience in the design, conduct, and review of cardiovascular outcomes trials in metabolic diseases.
Beyond his regulatory career, Dr. Sharretts has expertise from more than a decade working in clinical, academic, and research settings. After receiving his medical degree from the Medical College of Virginia/Virginia Commonwealth University and completing an Internal Medicine residency, he worked several years as the hospital physician for an interventional cardiology practice. He then completed a clinical fellowship in Endocrinology, Diabetes, and Metabolism at the National Institutes of Health before entering academic practice as an Assistant Professor of clinical medicine at the University of Pennsylvania and Philadelphia VA Medical Center. He also holds an M.S. in biomedical engineering from the University of Virginia.