Robert Temple

Senior Advisor for Clinical Science, FDA, USA

Title: TBA

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Biography

Dr. Robert Temple serves as Senior Advisor for Clinical Science in CDER’s Office of the Center Director and Senior Advisor in the Immediate Office of the Office of New Drugs. 

Robert Temple, MD, has a long-standing interest in the design and conduct of clinical trials. He has written extensively on this subject, especially on choice of control group in clinical trials, evaluation of active control trials, trials to evaluate dose-response, and trials using “enrichment” designs. Serving as CDER’s deputy center director for clinical science, and also acting deputy director of the Office of Drug Evaluation I (ODE-I), he is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products. He is trained in internal medicine and clinical pharmacology. Early in his career, Dr. Temple joined the Clinical Endocrinology Branch of the National Institute of Arthritis, Metabolism, and Digestive Diseases at NIH. He was a reviewing medical officer in the Division of Metabolic and Endocrine Drug Products and became assistant to the director of the Bureau of Drugs, later becoming the director of the Division of Cardio-Renal Drug Products. For several years he served as director of the Office of Drug Research and Review. His contributions have been frequently recognized with numerous awards from professional societies and the government.

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