Hatch waxman act - Study guides, Class notes & Summaries

Ohio MPJE 2024 Questions and Answers Graded A+ Federal Food, Drug, and Cosmetic Act of 1938 The "Pillar of Pharmacy Law"; gave authority to FDA to oversee safety of food, drugs, and cosmetics Adulteration Contains any poisonous or deleterious substance which may render it injurious to users when used as directed Misbranded Drug that's labeling or packaging is false or misleading; contains incorrect drug, pt name, prescriber name, or directions Durham-Humphrey Amendment of 19...

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...

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...

Pharmacy Law - MPJE NYS Exam Questions And Answers Which of the following brand name products may not be substituted under New York's "negative formulary"? - Phenergan IR tablets, suppositories, solution for injection, oral suspension - ANS SUPPOSITORIES (along with ER formulations, they need to determine bioequivalence. Therapeutic equivalents that may be substituted must be... - ANS Bioequivalent and approved ANDA What are some enforcement tools utilized by the FDA? - 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 ...

Which of the following brand name products may not be substituted under New York's "negative formulary"? - Phenergan IR tablets, suppositories, solution for injection, oral suspension correct answers SUPPOSITORIES (along with ER formulations, they need to determine bioequivalence. Therapeutic equivalents that may be substituted must be... correct answers Bioequivalent and approved ANDA What are some enforcement tools utilized by the FDA? correct answers 1) Seizure of drugs 2) Criminal ...

CSA correct answers Controlled Substances Act (enforced by the DEA) Poison Prevention Packaging Act correct answers Sets child-resistant drug packaging requirements, under US Consumer Product Safety Commission HIPAA correct answers set by the department of health and human services CMEA correct answers Control Methamphetamine Epidemic Act (CMEA)- pseudoephedrine containing product requirements Hatch-Waxman Act correct answers included the ANDA approval process for generic drugs in...

1. How are drugs sorted into therapeutic groups and classes? A. first by the conditions that they are used to treat. and then by their mechanisms of action B. first by their mechanisms of action. and then by their therapeutic effects C. first by their side effects. and then by their therapeutic effects D. first by their toxicity. and then by their effectiveness 2. Bone marrow transplants... A. require that the patient first undergo chemotherapy or radiation to kill the diseased...

Utah MPJE-Federal Law Questions and Answers Graded A+ What does CFR relate to? federal regulations What does USC relate to? united states code (laws) What does UAC relate to? Utah administrative code What does UCA relate to? Utah code annotated (law) What are the 4 parts of negligence? duty (obligation by the individual to conform to a specific standard of conduct) breach- violation of that legal obligation by defendant causation- the breach is the actual and proximate cause...

NAPSR/CNPR Exam question and answers 2022/2023Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. True Average review time for a new drug 18 months Sales Team Pg 7 The "engine of innovation," focused on discovering or inventing promising new product. Research & Development This includes supply chain, manufacturing, trade, and distribution functions of the business. Ma...