Pure food and drug act - Study guides, Class notes & Summaries

PA MPJE 2024 QUESTIONS AND ANSWERS GRADED A+ Generic drug companies can submit what two abbreviated drug applications? ANDA or 505(b)(2) application What is the key difference between an ANDA and 505(b)(2) application? Drugs submitted under ANDA must be bioequivalent and have same route of administration, strength, and formulation Drugs submitted under 505(b)(2) can have different strength or formulation What Act approved in March of 2020 includes OTC monograph reform? The CARES Ac...

Nebraska MPJE Questions And Answers 100% Verified 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? - ANS-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? - ANS-FDA modernization act 1997 What act reduced the cose of orphan drugs? - ANS-...

North Carolina MPJE Questions and Answers Rated A+ Pure Food and Drug Act of 1906 prohibited the adulteration and misbranding of foods and drugs in interstate commerce Food, Drug, and Cosmetic Act of 1938 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 1951 Established two classes of medications: Rx and ...

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...

Who pass law (legislative body) that govern pharmacy practice in VA? - correct answer U.S congress and VA general assembly Who regulate (regulative body) pharmacy practice in VA? - correct answer FDA, DEA, and VA Board of Pharmacy What is the Pure Food and Drug Act of 1906? - correct answer Prohibits the shipment of adulterated or misbranded drugs in interstate commerce -have to meet quality and purity standards What is the Food, Drug, and Cosmetic Act of 1938? - correct answer Law tha...

According to the Quality System Regulation, when an investigation of a complaint is conducted all of the following are requirements for inclusion in the record of the investigation EXCEPT: A. The dates and results of the investigation B. The nature and details of the complaint C. Changes in procedures correcting quality problems D. Any reply to the complainant - Answer-C. A regulatory affairs professional wants to schedule a pre-NDA meeting with FDA. He or she should: A. Write a letter to...

Pure Food and Drug Act - correct answer Prevents the manufacturing, sale/transportation of misbranded or adulturated drugs, poisoned or contaminated drugs Adultered drugs - correct answer Any drug that is not pure misbranded drug - correct answer Not labeled correctly FDCA (Federal Food, Drug, and Cosmetic act) - correct answer drugs must comply with standards of safety and efficacy, more modern act than Pure Food and Drug Act. Oversees safety of food, drugs and cosmetics FDA...

What is the Pure Food and Drugs Act of 1906? - Drugs marketed as interstate must comply with standards with strength, purity, and quality Who is the father of the U.S. food and drug law? - Harvey Wiley What is the Federal Food, Drug, and Cosmetic (FDC) Act? - -107 sulfanilamide elixir deaths in 15 states -Diethylene glycol (antifreeze) caused kidney damage -Congress created FDA NDA -Applications needed to be filed with safety and quality, not necessarily efficacy What is the Durham-Hump...

Test Bank for Essentials of Pharmacology for Health Professions 8th Edition by Bruce Colbert & Ruth Woodrow ISBN 9781337395892 | Complete Guide A+. CHAPTER 1: CONSUMER SAFETY AND DRUG REGULATIONS TRUE/FALSE 1. The pharmaceutical manufacturer has the authority to add additional active ingredients to a previously approved pharmaceutical product. ANS: F According to the 1938 Federal Food, Drug, and Cosmetic Act and Amendments of 1951 and 1962, all labels must be accurate and include a listing of al...

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...