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RAPS RAC-US Exam (page: 3)
RAPS Regulatory Affairs Certification (RAC) US
Updated on: 25-Dec-2025

Viewing Page 3 of 21
RAC-US PDF 100 Questions

Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

  1. Proposed dose and volume of administration
  2. Biological activity with species and/or tissue specificity
  3. Immunochemical and functional tests
  4. Proposed product route and frequency of administration

Answer(s): B



Which of the following claims would classify an apple as a drug?

  1. "It will make you look younger."
  2. "It will satisfy hunger."
  3. "It will whiten teeth."
  4. "It will prevent colds."

Answer(s): D



The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?

  1. The process information and analytical result of Company X API
  2. The process information and analytical result of Company Y API
  3. The process information and the comparative analytical result of APIs from both companies
  4. Information deemed appropriate by the regulatory authority

Answer(s): C



Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?

  1. Fishbone analysis
  2. Failure modes, effects, and criticality analysis
  3. Fault tree analysis
  4. Quality by design analysis

Answer(s): B



A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?

  1. Label the product for use in appropriate populations.
  2. Educate patients and healthcare providers on how to use the product
  3. Delay product launch until required studies are completed.
  4. Promote off-label use to a carefully selected patient population.

Answer(s): D



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John 8/29/2023 8:59:00 PM

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Kenneth 12/8/2023 7:34:00 AM

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