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RAPS RAC-US Exam
Regulatory Affairs Certification (RAC) US (Page 2 )

Updated On: 19-Jan-2026
Page 2 of 21
PDF with 100 Questions

A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?

  1. Adverse event reports
  2. Clinical experience
  3. Clinical investigations
  4. Literature search

Answer(s): C



An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?

  1. Stop product manufacturing.
  2. Establish validation procedures.
  3. Assess the impact of the changes.
  4. Review the stability data for the changes.

Answer(s): A



Company X is planning to acquire the rights for a product marketed by Company Y. As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?

  1. Intellectual properly
  2. Clinical trial data
  3. Safety issues
  4. Marketing materials

Answer(s): C



During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.

What should be done in response to identifying the impurity?

  1. Perform either an identification study or a non-clinical qualification study.
  2. Perform both identification and non-clinical qualification studies concurrently.
  3. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
  4. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.

Answer(s): C



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?

  1. Acknowledge receipt of the letter in a written response but do nothing further.
  2. Inform the legal department of the letter and discuss how to respond.
  3. Inform Company X that it has no right to send such a letter and do nothing further.
  4. Inform the local regulatory authority of the letter and discuss how to respond.

Answer(s): B



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