FDA appoints another new CDER director, selecting Dr Tracy Beth Høeg
Posted: 4 December 2025 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
She will become the fifth leader at the Center, following the surprise retirement decision by her soon-to-be predecessor Richard Pazdur.
The US Food and Drug Administration (FDA) has assigned Dr Tracy Beth Høeg, PhD, as the acting director of the Center for Drug Evaluation and Research (CDER), moving quickly to quell another round of turmoil at the regulator.
She will succeed Richard Pazdur after his surprise decision to retire before the end of this year, having only taken up the post last month.
Although Dr Høeg has limited experience of medicine regulation, and will become the fifth CDER leader this year after Pazdur, George Tidmarsh, Jacqueline Corrigan-Curay and Patrizia Cavazzoni, she received a ringing endorsement from FDA leadership.
Commissioner Dr Marty Makary said: “Dr Høeg is the right scientist to fully modernise CDER and finish the job of establishing a culture of cross-centre coordination there.”
At CBER, she advanced scientific rigor through her commitment to providing the public with the highest quality of evidence, including our roadmap to reduce and replace animal testing with new technologies”
Physician and epidemiologist Dr Høeg previously served as Senior Advisor for Clinical Sciences in the FDA’s Office of the Commissioner and the Center for Biologics Evaluation and Research (CBER). Dr Pazdur replaced Dr George Tidmarsh after his resignation as its director in November.
Dr Makary added: “At CBER, she advanced scientific rigor through her commitment to providing the public with the highest quality of evidence, including our roadmap to reduce and replace animal testing with new technologies.”
Dr Tracy Beth Høeg’s earlier career
Before working at the FDA, 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.
She 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, US.
On her appointment, Dr Høeg said: “CDER plays a crucial role in ensuring the medicines we rely on are both safe and effective.
“.. I am committed to transparency, honesty, and decisions based on rigorous science and ensuring important changes happen efficiently. I am humbled to support the FDA’s work to modernise and strengthen how we evaluate evidence so the public benefits from the best science.”
