Nebraska MPJE Exam Study Guide | 175 Questions with 100% Correct Answers | Verified | Latest Update 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? - 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? - 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 the 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