Final answer:
The Kefauver-Harrison Amendment of 1962 established stringent drug safety regulations, mandating that drug manufacturers prove the efficacy and safety of drugs prior to FDA approval.
Step-by-step explanation:
The Kefauver-Harrison Amendment of 1962 established drug safety regulations. This amendment required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval.
It was enacted in response to the thalidomide tragedy, where a drug caused birth defects in thousands of babies. This amendment fundamentally altered the way pharmaceuticals are regulated in the United States and ensured that patients receive drugs that are both safe and effective.