Fda reporting - Study guides, Class notes & Summaries

Pure Food and Drug Act (1906) aka Wiley Law - correct answer Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) - correct answer -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) - correct answer -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills Manufacturer label on Rx drugs after Durham-...

NURS 306: Module 1 Questions and Answers 100% Pass **How is pharmacology best described?** **The study of how chemicals affect living organisms** **Which organization is likely involved if a drug is assigned a C-II abuse potential during the third phase of testing?** 1. Froggies and Dinosaur's Associates (FDA) 2. Drug Enforcement Agency (DEA) 3. Food and Drug Administration (FDA) **3. Food and Drug Administration (FDA)** **Your attending physician mentions the first phase of...

RAC Exam New Edition 2024 Solved Correctly drug - Answer ️️ -Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. medical device - Answer ️️ -An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or similar or relate article, including any component, part or accessory intended for the use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease on...

US RAC Review Questions And Answers 2024 RAPS Modules Updated with Complete Solution. In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your appr...

What is a statute? - Answer A law What is administrative law? - Answer Rules and regulations created by administrative agencies such as the FDA and Indiana Board of Pharmacy What was accomplished by the pure food and drug act of 1906? - Answer Prohibited adulteration and misbranding of foods and drugs in interstate commerce (does NOT include that misbranding includes false or misleading efficacy claims) What was accomplished by the food, drug, and cosmetic act of 1938? - Answer...

_____________ is a better predictor of heart disease than _______________ - HDL ; total cholesterol __________________ are not regulated by the FDA - herbal medicines -brain and spinal chord -Spinal cord receives sensory information from the body & sends it to the brain, and receives motor information from the brain & sends it to the body - Central Nervous System (CNS) -characterized by a loss of dopamine neurons, primarily in substance viagra -abnormal aggregates of proteins within neuro...

What is the purpose of the ICH's Good Clinical Practice: consolidated Guideline? - To define Good clinical practice and provide a unified standard for designing, conduction, recording and reporting trials that involve participation of human subjects. What guideline's purpose is to define Good clinical practice and provide a unified standard for designing, conduction, recording and reporting trials that involve participation of human subjects? - ICH's Good Clinical Practice: Consolidated Guid...

NURS 615 Exam 3 Questions And Answers 2023 Rated A+ ( Chapter 25 - 36). Chapter 25. Drugs Used in Treating Inflammatory Processes 1. Henry presents to clinic with a significantly swollen, painful great toe and is diagnosed with gout. Of the following, which would be the best treatment for Henry? 1. High-dose colchicine 2. Low-dose colchicine 3. High-dose aspirin 4. Acetaminophen with codeine Ans: 2 2. Patient education when prescribing colchicine includes: 1. Colchicine may be consti...

Pure Food and Drug Act - correct answer Prevents the manufacturing, sale/transportation of misbranded or adulturated drugs, poisoned or contaminated drugs Adultered drugs - correct answer Any drug that is not pure misbranded drug - correct answer Not labeled correctly FDCA (Federal Food, Drug, and Cosmetic act) - correct answer drugs must comply with standards of safety and efficacy, more modern act than Pure Food and Drug Act. Oversees safety of food, drugs and cosmetics FDA...

SOCRA Questions and Answers Already Passed When isn't an IND application needed? IND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) -FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Additional information (drug dependen...