: SAGE: Kefauver-Harris Amendments

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Kefauver-Harris Amendments

The impetus for the 1962 Kefauver-Harris Amendments to the Food, Drug, and Cosmetic Act was thalidomide-induced birth defects that affected more than 300 infants born between 1960 and 1961 in the United States. The thalidomide tragedy had its origins in western Europe, where it was introduced as a new sleeping pill. [Source: Encyclopedia of Health Care Management; Kefauver-Harris Amendments]

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