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avatar for James Smith

James Smith

FDA, United States
Deputy Director, Office of New Drug Policy, OND, CDER
Dr. Smith is deputy director of the Office of New Drug Policy in the Office of New Drugs (OND), with his primary focus being clinical and scientific policy priorities. He was formerly deputy division director of the Division of Metabolism and Endocrinology Products, overseeing development programs targeting diseases ranging from the very rare to the very common. Dr. Smith is a graduate of the University of Michigan Medical School and completed an Internal Medicine residency at the same institution before fellowships in both nephrology and clinical pharmacology at Vanderbilt University Medical Center. He also holds a master's degree in Clinical Research Design and Statistical Analysis from the University of Michigan School of Public Health.