Ellis Unger Principal Drug Regulatory Expert 202-870-7897
Ellis Unger

Overview

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 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.

Dr. Unger was involved in drafting of dozens of FDA Guidance documents and numerous working groups (including FDA’s Benefit-Risk framework). He served as an FDA representative on a number of expert working groups at the International Council on Harmonization, making key contributions to several efficacy guidelines: E2F (Development Safety Update Report, DSUR), E2C(R2) (Periodic Benefit-Risk Evaluation Report, PBRER), and E19 (Safety Data Collection), as well as M4E(R2), the benefit-risk section of the Common Technical Document.

Dr. Unger obtained his Medical degree from the University of Cincinnati College of Medicine in 1980, and was inducted into the Alpha Omega Alpha Medical Honor Society. Following his residency in Internal Medicine at the Virginia Commonwealth University, he obtained cardiology training at The Johns Hopkins Hospital in 1987. While at Johns Hopkins, and as a Senior Investigator in the Cardiology Branch, National Heart, Lung and Blood Institute, NIH, Dr. Unger led a translational research program on the promotion of angiogenesis for ischemic cardiovascular disease