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
ANS: D
Prior to 1962, manufacturers of new drug products were only required to prove that their products were safe for marketing.
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