When Frances Oldham Kelsey, MD, PhD, began her job as a medical reviewer in a dreary prefabricated building at the US Food and Drug Administration (FDA) in 1960, her first assignment was to review an “easy” application for the US marketing of a drug that was already widely used in Europe and thought to be safe. Neither she nor her supervisors could have predicted that her work on the application would spark changes in drug regulation worldwide and lead to the development of modern standards for clinical research.
Kuehn BM. Frances Kelsey Honored for FDA Legacy. JAMA. 2010;304(19):2109-2112. doi:10.1001/jama.2010.1652