Durham humphrey amendment Study guides, Class notes & Summaries

Pure Food and Drug Act of 1906 (Wiley Act) - correct answer Prevents adulteration and misbranding Drugs met standard of strength/quality/purity according to USP/NF Food, Drug, and Cosmetic Act of 1938 - correct answer Required manufacturer to prove drug safety prior to marketing it Also defined/regulated: adulteration, misbranding, interstate commerce Durham Humphrey Amendment of 1951 - correct answer Divided medications into OTC and prescription (legend) drugs Kefauver-Harris Amend...

Nebraska MPJE Questions and Answers Already Passed 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...

Pure Food and Drug Act of 1906 (Wiley Act) Prevents adulteration and misbranding Drugs met standard of strength/quality/purity according to USP/NF Food, Drug, and Cosmetic Act of 1938 Required manufacturer to prove drug safety prior to marketing it Also defined/regulated: adulteration, misbranding, interstate commerce Durham Humphrey Amendment of 1951 Divided medications into OTC and prescription (legend) drugs Kefauver-Harris Amendment of 1962 Manufacturer's must prove that a drug is bo...

Pure Food and Drug Act of 1906Answer - prohibited the adulteration and misbranding of foods and drugs in interstate commerce Food, Drug, and Cosmetic Act of 1938Answer - Core of today's drug laws. No new drug can be marketed/sold until proven safe and approved by FDA. Labels must contain adequate directions for use and warnings about their habit-forming properties Durham-Humphrey Amendment of 1951Answer - Established two classes of medications: Rx and OTC. Authorized oral prescriptions...

Maryland MPJE Questions and Answers Already Passed Pure Food and Drug Act of 1906 (Wiley Act) Prevents adulteration and misbranding Drugs met standard of strength/quality/purity according to USP/NF Food, Drug, and Cosmetic Act of 1938 Required manufacturer to prove drug safety prior to marketing it Also defined/regulated: adulteration, misbranding, interstate commerce Durham Humphrey Amendment of 1951 Divided medications into OTC and prescription (legend) drugs Kefauver-Harris Amendment of 1...

Which FDCA amendment exempted certain drugs from the "adequate directions for use" labeling requirement if they bear "Rx only" on their labels? a. Durham Humphrey b. Kefauver-Harris c. Prescription Drug Marketing d. Waxman-Hatch - Answer a. Durham Humphrey The FDCA defines a "new drug" as a previously approved drug entity with a new: a. route of administration. b. indication for use. c. combination of ingredients. d. a and b e. a, b and c. - Answer e. route of administrat...

Administrative Procedure Act - correct answer federal law enacted in 1946, "notice and comment rulemaking" 1906: The Pure Food and Drug Act (PFDA) - correct answer interstate commerce labeling 1912 Pure Food and Drug Act - correct answer revised in 1912, stated that a drug was misbranded if its label contained a "false and fraudulent" statement regarding "curative or therapeutic effect." 1938 FD&C Act - correct answer • extended control to cosmetics and therapeutic de...

Nebraska MPJE | 176 Questions with 100% Correct Answers 2022/2023 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? Correct Answer: 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? Correct Answer: FDA modernization act 1997 What act re...

Durham-Humphrey Amendment Correct Answer Created 2 classes of drugs: OTC and Rx Kefauver-Harris Amendment Correct Answer This requires drug manufacturers to provide proof of safety and efficacy. Drug Importation Correct Answer Florida allows drug importation from Canada, but no plan has been approved yet by the HHS Drug Quality and Security Act - DSQA Correct Answer distinguishes compounding from manufacturing 503A vs 503B facilities Correct Answer 503A: may only compound persuant to...

1. Pure Food and Drug Act of 1906 (Wiley Act) ANS Prevents adulteration and mis- branding Drugs met standard of strength/quality/purity according to USP/NF 2. Food, Drug, and Cosmetic Act of 1938 ANS Required manufacturer to prove drug safety prior to marketing it Also defined/regulated ANS adulteration, misbranding, interstate commerce 3. Durham Humphrey Amendment of 1951 ANS Divided medications into OTC and prescription (legend) drugs 4. Kefauver-Harris Amendment of 1962 ANS Manufact...