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

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)