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Abstract
In 1962, President Kennedy signed into law the Kefauver–Harris Amendments to the Federal Food, Drug, and Cosmetic Act. Many issues covered by provisions cut from the bill continue to confront those who would ensure access to innovative, safe, efficacious, affordable therapeutics.
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1 From the Departments of Medicine and the History of Medicine, Johns Hopkins University School of Medicine, Baltimore (J.A.G.); and the Department of Global Health and Social Medicine, Harvard Medical School, and the Center for the History of Medicine, Francis Countway Library of Medicine — both in Boston (S.H.P.).