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Reform, Regulation, and Pharmaceuticals — The Kefauver–Harris Amendments at 50

2012; Massachusetts Medical Society; Volume: 367; Issue: 16 Linguagem: Inglês

10.1056/nejmp1210007

1533-4406

Jeremy A. Greene, Scott H. Podolsky,

Biomedical Ethics and Regulation

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.