Julie G. Beitz, M.D.

Dr. Beitz has broad experience in assessing the safety and effectiveness of new drug and biologic products and in regulatory decision-making.  She is a medical oncologist/hematologist and has served in leadership positions in FDA’s Center for Drug Evaluation and Research (CDER) for nearly three decades.

From early 2020 until her retirement from FDA in July 2023, Dr. Beitz was the Director of the Office of Immunology and Inflammation in CDER’s Office of New Drugs (OND), with oversight of review divisions responsible for therapeutics in dermatology, gastroenterology, hepatology, rheumatology, and pulmonology.  From 2006 to 2020, she was the director of the Office of Drug Evaluation III with supervision of review divisions responsible for gastroenterology, hepatology, inborn errors of metabolism, dermatology, bone disorders, gynecology, and urology.  In her 17-year tenure as an Office Director, Dr. Beitz was responsible for regulatory decisions involving countless therapeutic products. She supervised preparation for Advisory Committee meetings and served as the deciding authority on formal dispute resolution requests submitted by companies to the Office level.

Dr. Beitz joined the FDA in 1994 initially as a medical officer in OND’s Division of Oncology Drug Products and quickly assumed roles of increasing responsibility.  In 2000, she became Director of the Division of Drug Risk Evaluation in CDER’s Office of Surveillance and Epidemiology.  In this capacity she managed the evaluation of postmarket safety issues involving numerous drug and biologic products.

Dr. Beitz received her medical degree in 1981 from the College of Physicians and Surgeons, Columbia University.  She completed a residency in Internal Medicine and fellowship training in Medical Oncology/Hematology at Brown University Affiliated Hospitals. From 1987 to 1994 she served as Assistant Professor of Medicine (Research) at Brown, conducting translational research in tumor angiogenesis in an effort to identify potential targets for therapeutic intervention.  She also directed the Cancer Screening Program at Roger Williams Medical Center.