Ellis Unger, M.D.

Dr. Unger focuses on the development of promising new drug and biological therapies and shepherding them through the FDA approval process. A board-certified cardiologist with more than 24 years of experience at FDA and 14 years of experience in translational research at the National Institutes of Health (NIH), Dr. Unger provides strong scientific and regulatory insight.

Dr. Unger advises biotech and pharmaceutical senior executives and development teams on strategic direction at critical moments during drug development, from phase 1 matters to complex phase 3 study design issues. Formerly the FDA lead at numerous advisory committee meetings, he provides expert advice on advisory committee preparation. Key to his success is his ability to anticipate, understand, and address FDA concerns throughout drug development.

From early 2020 until his FDA retirement in August 2021, Dr. Unger was the Director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN) in CDER’s Office of New Drugs, with oversight of the reviewing divisions in those therapeutic areas. From 2012 to 2020, he was the Director of the Office of Drug Evaluation-I, which oversaw the regulation of drugs in the neurological, psychiatric, cardiovascular, and renal therapeutic areas. In his 9-year tenure as an FDA Office Director, Dr. Unger was directly involved in the regulation and approval of scores of new drugs and therapeutic biologics.

Dr. Unger joined the FDA in 1997, initially as a medical officer, team leader, and subsequently branch chief in FDA’s Center for Biologics Evaluation and Research (CBER). When regulatory authority for therapeutic biologics was transferred from CBER to CDER in 2003, Dr. Unger joined CDER as the Deputy Director of the Division of Cardiovascular and Renal Products. In 2009, Dr. Unger was promoted to Deputy Director, Office of Drug Evaluation-I under then-director Robert Temple. Dr. Unger became Director of that Office in 2012.

Throughout his FDA career, Dr. Unger mentored dozens of FDA reviews and more senior staff. He was well known for his expertise and insights in the analysis, interpretation, and display of various forms of data. He was also recognized as a creative leader in the safety assessment of drugs and biologics, as well as the consideration of complex benefit-risk scenarios.