Orphan drug act - Study guides, Class notes & Summaries

Table of Contents 1 Chapter 01 - Introduction to Drugs Chapter 02 - Drugs and the Body Chapter 03 - Toxic Effects of Drugs Chapter 04 - The Nursing Process in Drug Therapy and Patient Safety Chapter 05 - Dosage Calculations Chapter 06 - Challenges to Effective Drug Therapy Chapter 07 - Introduction to Cell Physiology Chapter 08 - Antiinfective Agents Chapter 09 - Antibiotics Chapter 10 - Antiviral Agents Chapter 11 - Antifungal Agents Chapter 12 - Antiprotozoal Agents Chapter 13 - Anthelmintic A...

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...

EXCPT PRACTICE EXAM B PHARM TECH EXAM 2024 WITH 100% CORRECT ANSWERS 76. A pharmacy technician is preparing to dispense a prescription. Which of the following findings is an indication that the prescription might be altered or forged? handwriting is illegible written in red ink uses multiple abbreviations unusually small dosage - correct answer Written in red ink 77. A pharmacy technician should identify that which of the following organizational procedures encourages reporting of ...

What is the 1938 Federal Food, Drug and Cosmetic Act? (Ans- Misbranding and mislabeling What is the 1951 Durham-Humphrey Amendment? (Ans- Distinction between legend drugs and otc drugs What is the 1970 Poison Prevention Packaging Act? (Ans- Made sure all manufacturers and pharmacies to place medications with childproof caps and packaging What is the 1983 Orphan Drug Act? (Ans- Encourages companies to develop drugs for rare diseases by providing research assistance, grants and co...

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...

1906 Federal Food and Drug Act correct answer: outlawed the sale of adulterated or misbranded products 1914 Harrison Narcotic Act correct answer: put taxes on anyone that traded opium (bases of cocaine) 1970 Controlled Substance Act*** correct answer: put medications in 5 classes with different regulations; consolidates many laws regulating the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, as well as chemicals used in production of...

Table of Contents 1 Chapter 01 - Introduction to Drugs Chapter 02 - Drugs and the Body Chapter 03 - Toxic Effects of Drugs Chapter 04 - The Nursing Process in Drug Therapy and Patient Safety Chapter 05 - Dosage Calculations Chapter 06 - Challenges to Effective Drug Therapy Chapter 07 - Introduction to Cell Physiology Chapter 08 - Antiinfective Agents Chapter 09 - Antibiotics Chapter 10 - Antiviral Agents Chapter 11 - Antifungal Agents Chapter 12 - Antiprotozoal Agents Chapter 13 - Anthe...

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...

ExCPT Pharm Tech Practice Exam B with Verified Answers |Latest 2024/2025 76. A pharmacy technician is preparing to dispense a prescription. Which of the following findings is an indication that the prescription might be altered or forged? handwriting is illegible written in red ink uses multiple abbreviations unusually small dosage ️ Written in red ink 77. A pharmacy technician should identify that which of the following organizational procedures encourages reporting of medication err...

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-...