Pma 3 review - Study guides, Class notes & Summaries

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 approved drugs in a new combination - Answer-C) You intend to collect blood samples from s...

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 ...

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 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...

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

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...

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...

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 ...

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...

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...