Pma 2 review - Study guides, Class notes & Summaries

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-Harris Amendments (1:2) - Answer-D: Kefauver-Harris Amendments The ...

What makes up a quality asphalt mixture? - A quality asphalt mixture is determined by the constructability, if it conforms to Specifications, and if it satisfies functional requirements. CQC - contractor quality control Superpave - Asphalt mix design system since 1998 QCP - Quality control plan QCM - Quality control Manual QC - Quality Control (Contracting Testing and Inspection) VT - Verification Testing (FDOT or CEI Verification) CEI - Construction Engineering and Inspection RT - Reso...

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...

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...

US RAC Review Questions RAPS Modules With Complete Solutions Latest Update 2023/2024 (Verified Answers). drug, which of the following studies would typically be conducted first: A) 1 month repeat dose toxicology study B) Single dose escalation PK study in healthy volunteers C) Multiple dose PK study in healthy volunteers D) Single dose escalation study in hypertensive patients:  B) Single dose esca- lation PK study in healthy volunteers 3. A sponsor must report an unexpected, fat...

US RAC Review Questions RAPS Modules With Complete Solutions (Latest Update) 2023 | Verified Answers. 1. 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 u...

ICH is an abbreviation for: International Conference on Harmonisation International Committee on Harmonizing Research Intercontinental Committee of Health Internal Council for Healthy subjects correct answersInternational Conference on Harmonisation You are a product manager at a medical device company in charge of ensuring the company's newest medical device follows the most appropriate regulatory pathway to approval. The device is classified as a significant risk Class III dev...

RAC Device Exam Questions and answers Graded A+ What did the safe medical device act do? - ANSExtended AE reporting to user facilities, required 510ks with SE, recall authority General controls - ANSEstablishment reg and device listing, GMP, labels, clearance before marketing What controls are required by the 3 US classes? - ANSClass 1 - general controls. Class 2- General and special controls (which include special labeling, PMS, and performance data) Class 3- general, special, and PMA ...

US RAC Review Questions RAPS Modules Questions and Answers | Latest Update | 2024/2025 | Already Passed What is the main purpose of the Risk Evaluation and Mitigation Strategies (REMS)? A) To ensure that the benefits of a drug outweigh its risks B) To promote sales strategies C) To conduct patient surveys D) To facilitate drug manufacturing Which regulatory submission is required for a device that is significantly different from existing products? A) Premarket Approval (PMA) B) 51...

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...