The Drug Amendment to the Food,Drug,and Cosmetic Act,enacted in 1962,gives the Food and Drug Administration broad powers to license new drugs in the United States.

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The Drug Amendment to the Food, Drug, and Cosmetic Act, also known as the Kefauver-Harris Amendment, was enacted in 1962 and granted the FDA expanded powers and requirements for drug approval, including the demonstration of safety and effectiveness before a drug can be marketed.