The US Food and Drug Administration (FDA) has named Tracy Beth Høeg, M.D., Ph.D., currently Senior Advisor for Clinical Sciences in the Office of the Commissioner and the Center for Biologics Evaluation and Research at FDA, as Acting Director of FDA’s Center for Drug Evaluation and Research (CDER). She takes over from former CDER Director, Richard Prazur, who was named CDER Director last month (November 2025) and has since left the post. CDER is the center within FDA that regulates prescription drugs and over-the-counter drugs, both innovator drugs and generic drugs and biosimilars. 

Dr. Høeg’s appointment as the new head of CDER comes with several leadership changes at CDER in 2025. Prazur served as CDER Director for a single month, being appointed in November 2025. He took over from former CDER Director, Dr. George Tidmarsh, M.D., Ph.D., who was CDER Director for only a few months having been appointed in July (July 2025) and leaving the post earlier in November 2025. He had taken over from Dr. Jacqueline Corrigan-Curay, M.D., who served as CDER’s Acting Director from January to July 2025 after its former head, Patrizia Cavazzoni, M.D., stepped down earlier in January (January 2025). Cavazzoni served as Director of CDER from April 2021 to January 2025.  

Prior to her appointment as Acting Director at CDER, Dr. Høeg was a Visiting Scholar at the Massachusetts Institute of Technology Sloan School of Management and practiced physical and interventional spine and sports medicine before joining FDA as Senior Advisor for Clinical Sciences in the Office of the Commissioner and the Center for Biologics Evaluation and Research.  

Dr. Høeg completed her Doctor of Medicine at the Medical College of Wisconsin, Doctor of Philosophy in Public Health and Epidemiology at the University of Copenhagen, and residency at the University of California, Davis.  

Source: US Food and Drug Administration