RAC Sample Test

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 - Answer- 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 - Answer- 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 C. Determine whether this is a New Chemical Entity D. Import the product and use new labeling - Answer- D. Import the product and use new labeling Question Feedback: The importation of a drug product to be distributed in the US must meet US regulations, regardless of its approved status in another country, therefore answer 4 is correct. A company is developing a combination product consisting of a device that injects a specially formulated small molecule drug for pain into the muscle tissue. Which of the following describes the best US regulatory path: A. The product is regulated as a drug B. The product is regulated under CDRH C. The company