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FDA Commissioner names George Tidmarsh as new CDER director
The FDA appointed Stanford physician-scientist and ex-biopharma executive George Tidmarsh as director of its largest division, the Center for Drug Evaluation and Research.
FDA Commissioner Marty Makary has named George Francis Tidmarsh, M.D., Ph.D., the new Director of the Center for Drug Evaluation and Research, succeeding acting director Jacqueline Corrigan-Curay.
Effective immediately, Tidmarsh, a former biopharma executive and Stanford-affiliated pediatrician, will oversee the FDA's largest division, responsible for regulatory review and post-market safety monitoring of prescription drugs, over-the-counter medications, biologics and generics.
"Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development, from bench to bedside," FDA Commissioner Marty Makary, M.D., M.P.H., said in today's press release. "His appointment to lead the Center for Drug Evaluation and Research (CDER) brings exceptional scientific, regulatory and operational expertise to the agency."
Expertise and academic credentials
As noted in the agency's press release, Tidmarsh earned his medical degree and a doctorate in cancer biology from Stanford University School of Medicine. He then completed a pediatric residency and two specialized pediatric oncology and neonatology fellowships.
Tidmarsh holds 143 scientific publications and patents, was the founding co-director of Stanford's Master of Translational Research and Applied Medicine program and has served as an advisor to academic, government and private organizations.
He has also spearheaded the clinical development of seven FDA-approved drugs and founded and served as CEO of several biopharmaceutical companies specializing in oncology and critical care medicine.
Regulatory modernization
Tidmarsh's appointment comes as the agency has advanced several regulatory modernization initiatives designed to streamline the drug approval process. These include the recent launch of the FDA's National Priority Voucher program to expedite review timelines and the agency-wide implementation of the generative AI platform, Elsa, which assists staff with clinical protocol assessments, safety evaluations and enhancing internal workflows.
As the FDA continues to streamline its processes, Makary said he looks forward to working with the newly appointed CDER director "to strengthen drug review programs, foster innovation and advance cross-agency initiatives that improve health outcomes for the American public."
Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.