Nebraska MPJE | 176 Questions with 100% Correct Answers

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What legistation 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? - ✔✔Food and Drug A... dministration (FDA) Modernization Act 1997 What legistation encouraged manufacturers to conduct research for new uses of drugs and to submit SNDAs for these uses? - ✔✔FDA modernization act 1997 What act reduced the cose of orphan drugs? - ✔✔Orphan drug act 1983 What act prohibited the adulteration or misbranding of food and drugs? - ✔✔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? - ✔✔Pure food and drug act 1906 What amendment defined two categories - legend and OTC - ✔✔Durham-humphrey 1951 What amendment mandated there must be "adequate directions for use" on the manufacturer's label for OTC's - ✔✔Durham-Humphrey 1951 What amendment declared that all new drugs marketed in the U.S. had to be shown to be safe and effective - ✔✔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. - ✔✔Prescription Drug Marketing Act 1987 What act requires proper storage of drugs and maintenance of appropriate distribution records? - ✔✔Prescription Drug Marketing Act 1987 What act prohibits sale, purchase, or trade of any drug which was purchased by a public or private hospital or other health care entity? - ✔✔Prescription Drug Marketing Act 1987 [Show More]

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