Bold new leadership at CDER signals a push to modernize drug evaluation and accelerate evidence-based decisions. The FDA today announced that Tracy Beth Høeg, M.D., Ph.D., has been appointed acting director of the Center for Drug Evaluation and Research (CDER). A physician and epidemiologist by training, Dr. Høeg previously served as a Visiting Scholar at MIT Sloan School of Management and practiced physical and interventional spine and sports medicine before joining the FDA as Senior Advisor for Clinical Sciences in the Office of the Commissioner and the Center for Biologics Evaluation and Research (CBER).
Dr. Høeg earned her medical degree from the Medical College of Wisconsin, a Ph.D. in Public Health and Epidemiology from the University of Copenhagen, and completed a residency at the University of California, Davis. Her scholarly work includes 45 peer-reviewed publications in outlets such as the New England Journal of Medicine, Pediatrics, BMJ Evidence-Based Medicine, Morbidity and Mortality Weekly Report, Annals of Internal Medicine, Journal of Infection, and the International Journal of Epidemiology.
“Dr. Høeg is the right scientist to fully modernize CDER and complete the work of fostering cross-center coordination,” said FDA Commissioner Marty Makary, M.D., M.P.H. “In CBER, she advanced scientific rigor by prioritizing high-quality evidence and guiding our roadmap to reduce and replace animal testing with new technologies.”
Dr. Høeg added, “CDER plays a crucial role in ensuring medicines are safe and effective. This is an incredible opportunity to serve my fellow Americans. I am committed to transparency, honesty, and science-based decisions, and to ensuring important changes are implemented efficiently. I am humbled to support the FDA’s efforts to modernize and strengthen how evidence is evaluated so the public benefits from the best science.”
In line with CDER modernization, the FDA also announced a new leader for its Office of Nonprescription Drugs (ONPD). Dr. Karen Murry will become director of ONPD and oversee efforts to expand access to affordable over-the-counter options for Americans.
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The FDA, part of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biologics for human use, and medical devices. The agency also oversees the safety of the nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and the regulation of tobacco products.
