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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.

Answer: A

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.

Answer: D

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.

Answer: A

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

Answer: D

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

Answer: A

NEW QUESTION # 79
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