Rac drugs exam 2024 - Study guides, Class notes & Summaries

RAC Exam Practice Exam 2024 with complete solution 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: Proof of efficacy Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham- Humphrey Amendments b) Hatch-Waxman Act c) Controlled Substances Act d) Kefauver- Harri...

RAC DRUGS Final Exam With Correct Answers 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 sub...

RAC Exam practice test bank 2024 all possible questions and answers with complete solution 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: Proof of efficacy Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham- Humphrey Amendments b) Hatch-Waxman Act c) Cont...

RAC Exam practice test bank 2024 all possible questions and answers with complete solution 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: Proof of efficacy Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham- Humphrey Amendments b) Hatch-Waxman Act c) Cont...

RAC Practice Exam Questions and Answers | Latest Update | 2024/2025 | 100% Pass What is the primary purpose of regulatory affairs? A) To ensure product marketing strategies are effective B) To ensure compliance with laws and regulations in healthcare C) To manage sales and distribution D) To enhance customer service practices Which of the following is a common requirement for premarket approval of medical devices? A) Completion of an annual report B) Submission of clinical data...

US RAC Exam Prep (2023/2024) Already Graded A 30-day hold (aka 30-day safety review) Time frame between filing a protocol under an IND and the FDA approval to proceed with enrollment. Also, the time period between when a company submits an IND and when it can initiate a protocol. This timeline may be extended if FDA does not agree with the proposed protocol. (see "Clinical Hold.") 120-day Safety Report Amendment to an NDA containing a safety update due 120 days after the NDA is filed. 180-da...

RAC Practice Exam Latest Updated 2024 With Complete Solutions You have modified your 510(k)-cleared device with a Special 510(k). In which case would a Special 510(k) not be appropriate for the device? -You have changed the primary mechanism of action. Which Premarket Approval Application (PMA) supplements are NOT subject to user fee exemption? - Real Time Supplement A medical device company allows its sales force to maintain a product inventory in the field. The device has an expir...

RAC Practice Exam 1 Latest 2024 with complete solution Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of systems to ensure accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic records. D Est...

FDA Time Frames (Device) RAC Exam 2024 | 35 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+ Facility Registration - Devices - within XX days of application or manufacturing - 30 days Facility Re-Registration - Devices, Drugs & Biologics - Annual GLP & GCP Record Retention - 5 Years - from application or 2 Years - from approval or termination date IND/IDE (GCP) - Progress Report - Reporting requirements Sponsor report to FDA & IRB Investigator reports to Spon...

FDA Time Frames (Device) RAC Exam Questions & Answers 2023/2024 Facility Registration - Devices - within XX days of application or manufacturing - ANSWER-30 days Facility Re-Registration - Devices, Drugs & Biologics - ANSWER-Annual GLP & GCP Record Retention - ANSWER-5 Years - from application or 2 Years - from approval or termination date IND/IDE (GCP) - Progress Report - Reporting requirements Sponsor report to FDA & IRB Investigator reports to Sponsor & IRB - ANSWER-Annual -...