RAC Sample Test | Questions with 100% Correct Answers | Verified | Latest Update 2024

Which of the following is considered part of the Device Master Record? A. Employee training record B. Labeling specifications C. Design reviews D. Calibration records - B. Labeling specifications Question Feedback: Labeling specifications are part of the DMR A company has a new oral drug, GOODDRUG, it wishes to market in the US. Studies on intravenous GOODDRUG have been conducted by several academic centers demonstrating safety and efficacy and have been published in peer-reviewed journals. The most-appropriate method to gain approval would be by filing a: A. ANDA B. SNDA C. 505(b)2 D. 505(b)1 - C. 505(b)2 Question Feedback: Since the drug has been studied and those results published, a comparability study between IV and oral dosage forms is acceptable under a 505(b)2 Your company is considering a new drug product. It has been on the market for more than 30 years in a foreign country, but has never been approved in the US. To sell this product in the US, you may do the following immediately EXCEPT: A. Determine monograph or NDA status of the product B. Initiate clinical studies in the foreign country to support the claims since the clinical data are old and would not meet current requirements