Marketed drugs Guides d'étude, Notes de cours & Résumés

NJ MPJE QUESTIONS AND ANSWERS ALREADY PASSED Neither _____ nor _____ are required by an *ANDA*. -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. - misbranding Pure Food and Drug Act (1906) description -mandated accurate p...

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-...

Pure Food and Drug Act (1906) aka Wiley Law Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) -New drug could not be marketed unless safe -Required manufacturer label to have directions for use and warnings about habit forming drugs Durham-Humphrey Amendment (1951) -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills Manufacturer label on Rx drugs after Durham-Humphrey Amendment -Not required to have directions for ...

Rau's Respiratory Care Pharmacology Ch. 1 with Complete Solutions Respiratory Care Pharmacology Application of pharmacology to the treatment of pulmonary disorders and, more broadly, critical care. Pharmacology the study of drugs, including their origins, properties, and interactions with living organisms Pharmacokinetics Time course and disposition of a drug in the body, based on its absorption, distribution, metabolism, and elimination. Pharmacodynamics The mechanism of drug a...

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...

What did the Federal Controlled Substances Act do? Why was it implemented? - Answer- Legislators very concerned in the 1960s about legal and illegal drugs being abused They were given the opportunity to design an act/law Created the DEA to promulgate and enforce the law Created a closed system between: manufacturer, distributors, prescriber, dispenser, and patient. What did the Pure Food and Drug Act of 1906 do? - Answer- Prohibited the adulteration and misbranding of foods and drugs...

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...

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...

1906 Pure Food and Drug Act - Answer Prohibits the sale and transport of adulterated or mislabeled food, drinks and drugs. Prohibits the mislabeling and misbranding of products. 1938 Food, Drug and Cosmetic Act (FDCA) - Answer This act requires that manufacture prove a new drug is safe for human consumption. Toxicological studies - done on animals. Clinical trials - done on humans. Gave rise to the Food and Drug Administration. Manufacturer must submit New Drug Application (NDA) to...

Rank speed of absorption: Po, IM, IV - Answer-Po slowest, then IM, IV fastest Describe drug distribution in relation to protein binding - Answer-Protein binding- Most drugs form a compound and bind with plasma proteins. Drug molecules bound to plasma proteins are pharmacologically inactive. Only the free or unbound portions of the drug acts on the cells. Protein binding allows for some of the drug to be stored and others to be released as needed. This gives the constant blood level and decr...