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Enactment of which major federal drug regulations required that new drug products be proven both ...

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Enactment of which major federal drug regulations required that new drug products be proven both ...

Enactment of which major federal drug regulations required that new drug products be proven both safe and effective before they could be approved for sale in the United States?

a. Federal Food, Drug, and Cosmetic Act (FD&C Act), 1938
b. Comprehensive Drug Abuse Prevention and Control Act (Controlled Substances Act), 1970
c. Durham-Humphrey Amendment to the FD&C Act, 1951
d. Kefauver-Harris Amendment to the FD&C Act, 1962

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