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RAC Exam practice Questions with Correct Answers Graded A Download to get A perfect Score A generic drug is deemed bioequivalent to the RLD if in clinical bioequivalence studies the 90% confidence intervals for the ratio of population geometric means between the two treatments based on log-transformed data is contained within the equivalence limits of ____% - ____% for AUC and Cmax. a) 80 120 b) 75 125 c) 90 110 d) 80 125(3:2) - Answer -D: 80% and 125% A manufacturer of a therapeutic vacc...

DEVICE RAC EXAM QUESTIONSWITH CORRECT ANSWERS GRADED A DOWNLOAD TO SCORE A 510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluation except: A) High Flux Hemodialyzer B) Blood specimen collection device C) Piston syringe D) Cardiopulmonary bypass blood tubing - Answer -B A company wants to modify its device such that there is a major change to the fundamental scientific technology of the device. The FDA has publishe...

RAC Practice Exam 1 Update Questions with Verified Answers Download to Score 100% A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to market a - Answer -New chemical entity when the sponsor has a right of reference to all applicable published studies A clinical investigator will conduct Phase I pharmacokinetic studies on your drug product. This same investigator also receives a $30,000 retainer to be on the speaker's bureau for another of your company's prod...

2009 RAC Practice Exam Questions with Correct Answers Graded A Guaranteed Perfect Score Which of the following is NOT a responsibility of clinical investigators? A. Submitting notices to the IRB of deviations from the investigational plan. B. Maintaining records of receipt, use and disposi¬tion of investigational product. C. Reporting to the sponsor withdrawal of IRB approval. D. Submitting unanticipated adverse event reports to FDA. - Answer -D. Submitting unanticipated adverse event r...

US RAC Practice Exam Update Questions with Correct Answers Graded A Download (100 out of 100%) [Q] ____ reserve sample(s) from each lot shall be retained for ___ year(s) after expiration date of the last lot of the drug product containing the active ingredient. [A] 1. 1 [B] 1. 2 [C] 2. 2 [D] 2. 3 - Answer -[A] 1. 1 [Q] ______ ______ are exempt from the brief summary requirement. [A]Promotional labeling [B]Reminder advertisements [C]Package Inserts [D]Drug commercials - Answer -[B]Re...

RAC 2016 US RAC Practice Exam Questions with Correct Answers Guaranteed Pass 100% Download A 510(k) submission for any Class Ill device MUST include: A. Clinical results summary. B. Risk analysis. C. Stability evaluation, D. Certification and summary. - Answer -Explanation: Although the design control regulations applicable to all Class III devices require risk analysis as part of design validation (21 CFR 820.30(g)), the risk analysis is not required to be included in Class Ill 510(k)s...

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