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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q74-Q79):

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.

Answer: A

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.

Answer: D

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.

Answer: A

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

Answer: D

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

Answer: A


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