Adultered device - Study guides, Class notes & Summaries

TEA process - 21 CFR 330-14 add established ingredient to existing OTC monograph Request for Designation (RFD) - ask FDA if it is a drug, biological, device, combo HDE humanitarian device excempt - no effectiveness data required misbranded device - not cleared through 510k process (but needs one) adultered device - does not have PMA but needs one design input for device - requirements that must be met IDE (Investigational Device Exemption) - report within 5 working days: emergencies, use ...

Oberon's RAC Drugs Questions and Answers TEA process ANSWER 21 CFR 330-14 add established ingredient to existing OTC monograph Request for Designation (RFD) ANSWER ask FDA if it is a drug, biological, device, combo HDE humanitarian device excempt ANSWER no effectiveness data required misbranded device ANSWER not cleared through 510k process (but needs one) adultered device ANSWER does not have PMA but needs one design input for device ANSWER requirements that must be met I...

Indiana Law 2020 MPJE Cards With Latest Questions And Answers - does not "actually" have to have something wrong with it; we assume product has been adultered if it has gone through a situation in which is may have been --products can be misbranded AND adultered; not mutually exclusive-- Misbranding - - issues with the words associated with the product - *prescription label req's fall into "misbranding"* - pharmacists and pharmacies can misbrand products --products can...

Test information - - 120 questions - answer all questions; penalized for each left blank - 75 is the score (not a %) needed to pass Adulteration - - issues with the product itself - does not "actually" have to have something wrong with it; we assume product has been adultered if it has gone through a situation in which is may have been --products can be misbranded AND adultered; not mutually exclusive-- Misbranding - - issues with the words associated with the product ...

MA MPJE Exam with 1200+Questions and Answers RATED A+ 2023|2024 Why does the government regulate medical drugs? Correct answer: protect people from making risky choices and harming themselves Ma state law, how many hours may a pharmacist work? Correct answer: 12 hours per day Allowing people to care for themselves leads to what? Correct answer: market failures What are the 4 kinds of market failures? Correct answer: public goods Externalities Natural monopolies Information asymmet...

What is the Food, Drug, and Cosmetic Act of 1938? - ANSWER Passed by Congress Requires new drugs to prove their safety prior to marketing (the primary federal law dealing with food, drug, cosmetic, and medical device safety). Established the FDA. What is the Durham - Humphrey Amendment of 1951? - ANSWER Establishes 2 classes of drugs (Prescription and OTC). Allows for verbal prescriptions and prescription refills. What is the Kefauver-Harris Amendment of 1962? - ANSWER Requires drug com...

PSB 411 Law Exam 1 Review Chapter 1 Law: a framework through which people in a society resolve their disputes and problems in a way that does not involve force and consistently yields results that are acceptable to most of society Government regulates medicinal drugs very heavily because of the potential risks to users Orphan Drugs: sufficiently safe and effective to be marketed by the number of patients who need them is so small that it is not commercially feasible for manufacturer...

Indiana Law 2020 MPJE Cards With Latest Questions And Answers - does not "actually" have to have something wrong with it; we assume product has been adultered if it has gone through a situation in which is may have been --products can be misbranded AND adultered; not mutually exclusive-- Misbranding - - issues with the words associated with the product - *prescription label req's fall into "misbranding"* - pharmacists and pharmacies can misbrand products --products can be misbranded...