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NEW QUESTION 27
After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

  • A. Verify the procedure in the regulation for the corrections.
  • B. Resubmit the entire package.
  • C. Contact the legal department and ask them how to proceed.
  • D. Inform upper management immediately.

Answer: A

 

NEW QUESTION 28
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?

  • A. International import and export regulations
  • B. Doha Declaration in the TRIPS Agreement
  • C. The time frame in which the patent will expire
  • D. The stability of the drug in all zone conditions

Answer: D

 

NEW QUESTION 29
Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?

  • A. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
  • B. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
  • C. The device incorporates well-established technology that is already present in the market.
  • D. The manufacturer’s experience level with the type of IVD medical device is limited.

Answer: D

 

NEW QUESTION 30
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