Orphan drug act - Study guides, Class notes & Summaries

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 stage of new drug development involves giving the medication to large numbers of individuals with the disorder that the medication intends to treat? A. Developmental stage - phase 1 B. Developmental stage - phase 2 C. Developmental stage - phase 3 D. Postmarketing surveillance stage - C. Developmental stage - phase 3 Which legislation was enacted to stimulate development and availability of drugs to treat rare diseases? A. The Food and Drug Act of 1979 B. The Fast Tracking rules C...

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...

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 act 1983 What act prohibited the...

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...

Which drug information source gives information regarding nutritional supplements? A. LactMed Database B. Natural Medicines Comprehensive Database C. United States Pharmacopeia (USP)/National Formulary (NF) D. USP Dictionary of United States Adopted Names (USAN) and International Drug Names - C. United States Pharmacopeia (USP)/National Formulary (NF) Which statement provides a definition of the trade name of a drug? A. The name under which the drug is listed in the US Pharmacopeia B. Th...

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...

What legislation 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 legislation 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 act 1983 What act prohibited the adulteration or misb...

ExCPT Practice Exam B Pharm Tech Question and answers rated A+ 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 medi...

1. What is the 1938 Federal Food, Drug and Cosmetic Act?: Misbranding and mislabeling 2. What is the 1951 Durham-Humphrey Amendment?: Distinction between leg- end drugs and otc drugs 3. What is the 1970 Poison Prevention Packaging Act?: Made sure all manufac- turers and pharmacies to place medications with childproof caps and packaging 4. What is the 1983 Orphan Drug Act?: Encourages companies to develop drugs for rare diseases by providing research assistance, grants and cost incentives 5. ...