题目内容

The tragedy of elixir sulfanilamide caused more than 100 deaths because _____.

A. sulfanilamide was toxic
B. the solvent DEG was toxic
C. the drug was contaminated
D. the manufacturing process was not validated

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Which of the following statements about Food, Drug and Cosmetic Act was not true?

A. It was passed in 1938 as the result of thalidomide tragedy.
B. The FC&C Act of 1938 firstly specified the requirement of safety proof before a new drug was marketed.
C. The amendment in 1962 required manufacturers should provide the proof of effectiveness before a new drug was marketed.
D. The amendment in 1962 specified the package insert of a new drug also should be approved by the FDA before the new drug was marketed.

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