Nebraska MPJE|176 Review Questions Which Have Been Correctly Answered

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 Administration (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