The ________________ to the Food and Drug Act gave the FDA authority for the first time to approve drugs based on their proven effectiveness.

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The Kefauver Amendment of 1962 gave the FDA authority for the first time to approve drugs based on their proven effectiveness. Prior to the amendment, the FDA only had the authority to evaluate a drug's safety. The amendment was passed in response to the thalidomide tragedy, in which a drug given to pregnant women in Europe resulted in birth defects. The amendment required drug manufacturers to prove the effectiveness and safety of new drugs before they could be approved for sale in the United States.

The ________________ to the Food and Drug Act Gave the FDA