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Amendments to the 1938 Food, Drug, and Cosmetic Act passed. This is the first U.S. law regulating drug trials.

Date: 1962

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The Kefauver-Harris Amendments focus on ensuring greater efficacy and safety in human drug trials. Drug manufacturers are required to secure informed consent from trial participants, prove to the U.S. Food and Drug Administration (FDA) that their products are effective before advertising them, and disclose any serious side effects. The amendments emerge partially in response to the thalidomide tragedy.