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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q89-Q94):

NEW QUESTION # 89
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. Advise the senior management to send a "Dear Dr." letter.
  • C. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
  • D. No action is required since it is an off-label use.

Answer: A


NEW QUESTION # 90
What is the LAST stage in the development of a quality risk management process for a medical device?

  • A. Risk reduction
  • B. Risk analysis
  • C. Risk acceptance
  • D. Risk evaluation

Answer: C


NEW QUESTION # 91
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?

  • A. Physical processing and packaging
  • B. Introduction of the API starting material
  • C. Production of Intermediate(s)
  • D. Isolation and purification

Answer: A


NEW QUESTION # 92
Which of the following claims would classify an apple as a drug?

  • A. "It will make you look younger."
  • B. "It will prevent colds."
  • C. "It will satisfy hunger."
  • D. "It will whiten teeth."

Answer: B


NEW QUESTION # 93
A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?

  • A. Ask the trade association representative to provide an overview of the new product area to the marketing team.
  • B. Obtain competitor research and provide the information to the management team.
  • C. Summarize regulatory documents and history and provide the information to the management team.
  • D. Obtain regulatory documents and history and provide the information to R&D.

Answer: C


NEW QUESTION # 94
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