Steven Galson

Dr. Galson is a specialist in regulatory science, drug development, and public health policy, with a focus on the evaluation, approval, and oversight of medical products and clinical research. His work addresses regulatory frameworks for safe and effective therapeutics, including drug evaluation, regulatory transparency, and the modernization of clinical trial design and approval pathways. His areas of focus also include rare diseases and public health preparedness. Dr. Galson has contributed to national regulatory and clinical research initiatives through senior government and advisory roles, including serving as acting director of the US Food and Drug Administration’s Center for Drug Evaluation and Research and acting US surgeon general. His publications address regulatory science, clinical trials, drug development, and public health policy and have appeared in academic and practice-related journals such as The New England Journal of Medicine, the Journal of Biopharmaceutical Statistics, Public Health Reports, Environmental Health Perspectives, and Health Affairs, as well as in publications of the National Academies of Sciences, Engineering, and Medicine. Dr. Galson has also held senior executive roles in biopharmaceutical research and development and regulatory affairs, including at Amgen.