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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q74-Q79):
NEW QUESTION # 74
You discover that your company's top selling product in the last two years has been used off-label.
The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?
- A. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
- B. No action is required since it is an off-label use.
- C. Advise the senior management to send a "Dear Dr." letter.
- D. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
NEW QUESTION # 75
During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?
- A. Contact the marketing department to recall the product.
- B. Request that doctors stop using the product for the off-label indication.
- C. Allow doctors to use the product for the off-label indication.
- D. Communicate with the sales department to stop using the promotional materials.
NEW QUESTION # 76
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject is hospitalized for the purpose of product administration.
- B. Subject's hospitalization is prolonged during the clinical trial.
- C. Subject's hospitalization is due to an unscheduled hip operation.
- D. Subject is hospitalized due to complications of the product administration.
NEW QUESTION # 77
A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?
- A. Specification
- B. Formulation
- C. Property
- D. Justification
NEW QUESTION # 78
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?
- A. Failure modes, effects, and criticality analysis
- B. Fishbone analysis
- C. Fault tree analysis
- D. Quality by design analysis
NEW QUESTION # 79
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