FDA Appoints New CDER Director, George Tidmarsh

Published on: July 21, 2025

George Francis Tidmarsh, MD, PhD, founding co-director of Stanford’s Master of Translational Research and Applied Medicine program, has been appointed as the new director of the Center for Drug Evaluation and Research.

FDA announced on July 21, 2025 that George Francis Tidmarsh, MD, PhD has been appointed the new director of the agency’s Center for Drug Evaluation and Research (CDER), which is tasked with ensuring the safety and efficacy of drugs in the United States (1). Tidmarsh has more than 30 years of experience in biotechnology, clinical medicine, and regulatory science.

Academic and industry experience

Tidmarsh attended Stanford University where he earned a degree in medicine and a PhD in cancer biology, as well as completing a residency in pediatrics. He also completed two subspecialty programs at Stanford in pediatric oncology and neonatology and is the founding co-director of Stanford’s Master of Translational Research and Applied Medicine (M-TRAM) program. M-TRAM trains students and researchers on how to translate scientific research into real-world application.

“Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development—from bench to bedside,” said FDA Commissioner Marty Makary. “His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency. I look forward to working with him to strengthen our drug review programs, foster innovation, and advance cross-agency initiatives that improve health outcomes for the American public.”

New director's potential impact

A founder and CEO of multiple biopharmaceutical companies over the years, including La Jolla Pharmaceutical Company and Horizon Pharma, Tidmarsh has been involved with the clinical development of seven FDA-approved drugs from discovery through approval (2). Unlike previous CDER directors, Tidmarsh lacks previous experience in government, but has served as an expert on FDA panels (3).

It is speculated that Tidmarsh may play a role in reassessing FDA’s approach to prescription drug advertising (4). According to Bloomberg, Tidmarsh has expressed concerns about inconsistencies by FDA regarding the regulation “long-standing restrictions on off-label communication by manufacturers and questioned some vaccine makers’ ads during the pandemic” (4). Tidmarsh, according to Bloomberg, has also expressed concerns about fraud in academic science and funds a program supporting investigation of scientific fraud (4).

Tidmarsh has served on advisory boards across academia, government, and industry and has authored 143 scientific publications and patents.

“It is good to see a scientist and physician with phenomenal experience like Dr. Tidmarsh at the helm of CDER,” Aloka Srinivasan, a member of Pharmaceutical Technology®’s Editorial Advisory Board, and principal and managing partner of Raaha LLC, said of the appointment. “Dr. Tidmarsh understands how the pharmaceutical industry operates and the roadblocks to better treatment of many diseases. As a former FDA employee and a member of the pharmaceutical industry, I hope that he is able to change the culture of the office he is heading, and incorporate better understanding of their role, which, other than just approving drugs is to see the bigger picture and understand how the approval of a drug may affect the American public."

Former CDER director retired in January 2025

CDER’s previous director, Patrizia Cavazzoni, resigned in January 2025. She started with FDA as deputy director of operations of CDER and served as acting principal deputy commissioner of Food and Drugs briefly in 2019. In 2021, she was made the director of CDER.

“While I could spend a lot of time enumerating our achievements, I want to highlight our biggest success: our people and our culture,” Cavazzoni said in a letter to her colleagues at the time of her retirement. “As I leave CDER, I can say with confidence that the Center is at its strongest. We have hired and retained record numbers of the best scientists and professionals. We have built a cohort of world-class managers and executives who are solidly at the helm of our organization and will continue to lead CDER. And most important of all, we created a culture that fosters respect for one another, inclusion, accountability, and diversity of thought and life experience. Our culture is what makes us strong and resilient, and it’s the foundation of what we have accomplished and will accomplish in the future” (5).

References

FDA. Stanford Faculty Member George Tidmarsh, MD, PhD Named Director of Center for Drug Evaluation and Research. Press Release. July 21, 2025. https://www.fda.gov/news-events/press-announcements/stanford-faculty-member-george-tidmarsh-md-phd-named-director-center-drug-evaluation-and-research
Joseph, A. FDA Taps Biotech Veteran George Tidmarsh to Lead Drug Center. STATnews.com. July 21, 2025. https://www.statnews.com/2025/07/21/george-tidmarsh-fda-marty-makary-drug-center-director/
Samorodnitsky, D. FDA’s CDER Gets New Chief in Biopharma Veteran George Tidmarsh. BioSpace.com. July 21, 2025.
Langreth, R. and Hornblower, S. FDA Appoints Biotech Executive as Top Drug Regulator Under RFK Jr. Bloomberg.com. July 21, 2025.
Haigney, S. Cavazzoni Retires as CDER Director. PharmTech.com, updated Jan. 13, 2025. https://www.pharmtech.com/view/cavazzoni-retires-as-cder-director