The U.S. Food and Drug Administration (FDA) has appointed Dr. George Tidmarsh as the new Director of the Center for Drug Evaluation and Research (CDER), marking a significant leadership change in the agency’s drug regulation wing. The announcement was made on July 21, 2025, and comes under the administration of FDA Commissioner Robert Califf and Health and Human Services Secretary Xavier Becerra.

CDER oversees the evaluation and approval of most prescription and over-the-counter drugs in the U.S. The center plays a crucial role in ensuring that medications are safe and effective for the public. Dr. Tidmarsh succeeds acting director Jacqueline Corrigan-Curay, following the retirement of Patrizia Cavazzoni earlier this year.

Dr. George Tidmarsh holds both an M.D. and Ph.D. in cancer biology from Stanford University, where he currently serves as an adjunct professor. He has completed a residency in pediatrics and subspecialty fellowships in pediatric oncology and neonatology, earning dual board certifications. He also co-founded Stanford’s Master of Translational Research and Applied Medicine (M-TRAM) program to mentor future drug developers.

In the biopharmaceutical industry, Dr. Tidmarsh has led multiple companies, including serving as CEO of Horizon Pharma and founding Metronome Therapeutics. He has been involved in the clinical development of seven FDA-approved drugs, including therapies for severe malaria, septic shock, and gene therapy for rare diseases.

FDA Commissioner Dr. Marty Makary praised Dr. Tidmarsh’s “exceptional scientific, regulatory, and operational expertise,” expressing confidence in his ability to modernize drug review programs and foster innovation.

In his statement, Dr. George Tidmarsh emphasized the need to uphold scientific integrity, accelerate innovation, and ensure access to safe and effective medications. “I am honored to lead CDER and support its critical mission to protect and promote public health,” he said.

The FDA praised Dr. George Tidmarsh’s strong scientific credentials and practical industry experience, calling him a “uniquely qualified” leader who can guide the agency through evolving medical and regulatory landscapes.

As CDER director, Dr. Tidmarsh will oversee drug approval pipelines, post-market safety monitoring, and policy development related to pharmaceutical innovation, including cell and gene therapies.

His appointment follows the retirement of former CDER Director Dr. Patrizia Cavazzoni, who led the center through the COVID-19 pandemic and a period of accelerated drug authorizations.

Dr. George Tidmarsh begins his role immediately, with stakeholders across academia, industry, and public health closely watching how his tenure will influence the future of drug regulation in the United States.

(Rh/Eth/DJR/MSM/SE)