1983 orphan drug act - Study guides, Class notes & Summaries

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 ...

Nebraska MPJE Exam Studt Set |Question and Answers| #Latest Relaese 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 o...

Nebraska MPJE Exam Questions and Answers 100% Pass 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? - 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? - Answer- FDA modernization act 1997 What act reduced the cose of orphan drugs?...

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 medication errors? Inconsistent definition of medication errors Punitive...

B ExCPT Practice Exam B Question and answers 100% correct 2024 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 medicatio...

Nebraska MPJE Exam Questions and Answers 100% Pass 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? - 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? - Answer- FDA modernization act 1997 What act reduced the cose of orphan drugs?...

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 - Answer-Written in red ink 77. A pharmacy technician should identify that which of the following organizational procedures encourages reporting of medication errors? Inconsistent definition of medication errors Punitive consequen...

Nebraska MPJE | 176 Questions with 100% Correct Answers 2024 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? - -...

PPLE MODULE 2 Exam | Questions and Correct Answers | Latest Update 2024/2025 Pure Food and Drug Act - Answer -1906- LABELING Food Drug and Cosmetic Act - Answer -1938- SAFETY Kefauver-Harris Amendment to FD&C - Answer -1962- SAFETY AND EFFICACY, SUBSTANTIAL EVIDENCE ORPHAN DRUG ACT - Answer -1983 SUBPART H - Answer -1992- ACCELERATED APPROVAL FDAAA - Answer -2007- POST-MARKETING SAFETY AND CLINICAL TRIAL DATABASES FDASIA - Answer -2012- BREAKTHROUGH DESIGNATION Harvey Wiley, physicia...

ADVANCED PHARMACOLOGY-NR 508 EXAM REVIEW 2023/2024 effectiveness, safety, selectivity - CORRECT ANSWER-State the three (3) most important characteristics of any drug. No, all medications have side effects - CORRECT ANSWER-Is it possible to have a selective drug? Absorption, distribution, metabolism and excretion - CORRECT ANSWER-Define the four phases of pharmacokenetics. The nature and intensity of the response the drug has on the body - CORRECT ANSWER-Define pharmacodynamics. Evalu...