Rac drug - Study guides, Class notes & Summaries

RAC Sample Test (100 Questions) With 100% Correct Verified Answers

RAC Drugs Final Exam Study Guide 2024 | 45 Questions with 100% Correct Answers | Verified | Latest Update | Graded A+

Device RAC Exam Questions and Answers 100% AccurateDevice RAC Exam Questions and Answers 100% AccurateDevice RAC Exam Questions and Answers 100% AccurateDevice RAC Exam Questions and Answers 100% Accurate Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - ANSWER-C. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiot...

RAC Drugs Final Exam-with 100% verified solutions

RAC Chapter 16N (13) - Generic Drug Submission Questions and Answers What is considered a generic drug? ANSWER The term "generic drug" is not defined in the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) or in US Food and Drug Administration (FDA) regulations. It generally is used, however, to refer to a drug product with the same active ingredient, dosage form, strength and route of administration as a brand-name drug and for which FDA has concluded that the generic can be sub...

RAC Drugs Final Exam 2024 | 40 Questions with 100% Correct Answers | Verified | Latest Update | Graded A+

RAC Chapter 18N (15)- OTC Drug Products Questions and Answers In 1951 the Durham-Humphrey Amendment to the Federal Food, Drug,and Cosmetic Act (FD&C Act) established what three criteria that would limit a drug to prescription status: ANSWER • habit forming drugs • not safe for use unless supervised by a healthcare professional • limited to prescription use under a New Drug Application (NDA) What are the typical characteristics for OTC drugs? ANSWER • benefits clearly outweigh p...

RAC Drugs Final Exam-with 100% verified solutions

RAC DRUGS STUDY GUIDE TEST 2024. (EU) MA - CORRECT ANSWER Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA - CORRECT ANSWER National, centralised, mutual recognition, decentralized procedures MAH - CORRECT ANSWER A legal person or legal entity who must be established in the European Economic Area comprising of 28 member states. What does an MA include? - CORRECT ANSWER Active substance intern...

RAC Exam Practice 2024/2025 Questions and Answers 100% CorrectRAC Exam Practice 2024/2025 Questions and Answers 100% CorrectRAC Exam Practice 2024/2025 Questions and Answers 100% CorrectRAC Exam Practice 2024/2025 Questions and Answers 100% Correct Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - ANSWER-A: Proo...