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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q80-Q85):

NEW QUESTION # 80
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

  • A. Phase I clinical trials
  • B. Phase I and II clinical trials
  • C. Phase III clinical trials
  • D. Pre-clinical studies

Answer: C


NEW QUESTION # 81
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. Property
  • C. Justification
  • D. Formulation

Answer: C


NEW QUESTION # 82
Which of the following is MOST appropriate for the purpose of lot release of biologics?

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

Answer: B


NEW QUESTION # 83
At a recent scientific meeting, Company Y had two booths:
* At one booth, Company Y provided brochures on a completed Phase II study.
* In an adjacent booth, Company Y's sales professionals were promoting one of Company
Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company
Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?

  • A. Inform Company X that it has no right to send such a letter and do nothing further.
  • B. Inform the local regulatory authority of the letter and discuss how to respond.
  • C. Acknowledge receipt of the letter in a written response but do nothing further.
  • D. Inform the legal department of the letter and discuss how to respond.

Answer: D


NEW QUESTION # 84
A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?

  • A. Notify the regulatory authority.
  • B. Compare the approved text with the product label
  • C. Recommend an immediate product recall.
  • D. Inform the production team.

Answer: B


NEW QUESTION # 85
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RAC-US - Regulatory Affairs Certification (RAC) US Pass-Sure New Exam Cram

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