Nebraska MPJE Study Guide Questions 2024.

Nebraska MPJE Study Guide Questions 2024. What legislation was created for the provisions for the fast-track review of some NDA submissions to expedite approval of new drugs used to treat life-threatening conditions? - correct answer Food and Drug Administration (FDA) Modernization Act 1997 What legislation encouraged manufacturers to conduct research for new uses of drugs and to submit SNDAs for these uses? - correct answer FDA modernization act 1997 What act reduced the case of orphan drugs? - correct answer Orphan drug act 1983 What act prohibited the adulteration or misbranding of food and drugs? - correct answer Pure Food and Drug Act 1906 What act required tha active ingredients be placed on the label of a drug's packaging and that drugs couldn't fall below purity levels established by the USP or National Formulary? - correct answer Pure food and drug act 1906 What amendment defined two categories - legend and OTC - correct answer Durham-humphrey 1951 What amendment mandated there must be "adequate directions for use" on the manufacturer's label for OTC's - correct answer Durham-Humphrey 1951 What amendment declared that all new drugs marketed in the U.S. had to be shown to be safe and effective - correct answer Kefauver-Harris 1962 What act was passed to correct the problem of diversion from the normal distribution channels. Prohibits drug from being re-imported into the U.S. Except by the manufacturer of said drugs. - correct answer Prescription Drug Marketing Act 1987