Term
Which of the following was NOT a requirement of the original Food, Drug, and Cosmetic Act of 1938?
a. Proof of efficacy
b. Proof of safety
c. Authorized standards of identity
d. Safe tolerances for unavoidable poisonous substances |
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Definition
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Term
Which amendments to the FD&C Act resulted from the thalidomide tragedy?
a. Durham-Humphrey Amendments
b. Hatch-Waxman Act
c. Controlled Substances Act
d. Kefauver-Harris Amendments |
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Definition
| d. Kefauver-Harris Amendments |
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Term
The Color Additive Amendment of 1960 required FDA to prove that a color additive was unsafe before removing it from the market.
a. True
b. False |
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Definition
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Term
What has been described as "the most extensive change to the agency's practices since 1938"?
a. Prescription Drug User Fee Act of 1992
b. GMPs for the 21st Century initiative
c. Food and Drug Administration Modernization Act
d. Food and Drug Administration Amendments Act |
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Definition
| c. Food and Drug Administration Modernization Act |
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