West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

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Study for the West Virginia MPJE Exam. Includes flashcards and multiple-choice questions, each with hints and explanations. Prepare effectively for your pharmacy law exam!

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Which amendment is responsible for the creation of New Drug Application (NDA) and Supplemental New Drug Application (sNDA)?

  1. Durham-Humphrey Amendment of 1951

  2. Kefauver-Harris Amendment of 1962

  3. Food, Drug, and Cosmetic Act of 1938

  4. Drug Listing Act of 1972

The correct answer is: Kefauver-Harris Amendment of 1962

The Durham-Humphrey Amendment of 1951 established two classes of drugs prescription and over-the-counter. The Drug Listing Act of 1972 was focused on the registration of drug establishments and the listing of drugs with the FDA. The Food, Drug, and Cosmetic Act of 1938 was the first comprehensive legislation of food and drug safety. Therefore, none of these options are responsible for the creation of New Drug Application (NDA) and Supplemental New Drug Application (sNDA) except the Kefauver-Harris Amendment of 1962, which required drug manufacturers to provide evidence of the safety and efficacy of their drugs through the NDA and sNDA. This amendment also granted the FDA more authority to regulate drug advertising and enact stricter requirements for clinical trials.

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