Answer :
Final answer:
The Kefauver-Harris Amendment (1962) mandates drug manufacturers to prove safety and efficacy before marketing in the U.S. post the thalidomide discovery.
Explanation:
Kefauver-Harris Amendment (1962) is the federal drug law that requires manufacturers to provide proof of both safety and efficacy before marketing in the United States. This amendment was a response to the thalidomide tragedy and aimed to ensure thorough testing of drugs to prevent similar incidents.
Learn more about FDA drug law regulations and the thalidomide tragedy here:
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