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Kefauver-Harris Bill of 1962

Also known as the 1962 Amendments to the Food, Drug, and Cosmetic Act of 1938, the Kefauver-Harris bill required pharmaceutical firms to wait for FDA approval prior to marketing their product. By law, the FDA is supposed to review an NDA within 180 days, but no penalties for failure exist, and the FDA has never come close to meeting this requirement. Additionally, the 1962 Amendments required the firm to show that a drug is efficacious in addition to safe for all labeled uses. The 1962 Amendments also brought clinical research and development under the authority of the FDA.

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