RAC-US Exam Question 1

During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?
  • RAC-US Exam Question 2

    During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
    Which action is MOST appropriate for the regulatory affairs professional to take?
  • RAC-US Exam Question 3

    In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?
  • RAC-US Exam Question 4

    Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?
  • RAC-US Exam Question 5

    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?