RAPS RAC-US DESKTOP PRACTICE TEST SOFTWARE

RAPS RAC-US Desktop Practice Test Software

RAPS RAC-US Desktop Practice Test Software

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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q78-Q83):

NEW QUESTION # 78
Which of the following is NOT required to be included in a marketing application?

  • A. Quality, safety, and efficacy Information
  • B. Administrative forms
  • C. Final printed label
  • D. Evidence of fee payment

Answer: D


NEW QUESTION # 79
Which of the following is MOST appropriate for the purpose of lot release of biologics?

  • A. Inventory control
  • B. Efficacy confirmation
  • C. Quality verification
  • D. Safety assurance

Answer: C


NEW QUESTION # 80
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. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
  • B. No action is required since it is an off-label use.
  • C. Advise the senior management to send a "Dear Dr." letter.
  • D. Discuss with regulatory authorities to investigate how to have the off-label indication approved.

Answer: D


NEW QUESTION # 81
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

  • A. Inform the internal departments to redesign the product to comply with this requirement.
  • B. Notify senior management that the product cannot be registered.
  • C. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
  • D. Inform the regulatory authority that such a requirement is not applicable to the product.

Answer: C


NEW QUESTION # 82
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. Communicate with the sales department to stop using the promotional materials.
  • 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. Contact the marketing department to recall the product.

Answer: A


NEW QUESTION # 83
......

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