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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q29-Q34):

NEW QUESTION # 29
Which of the following statements regarding the off-label use of drugs is CORRECT?

• A. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
• B. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.
• C. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
• D. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.

Answer: A
NEW QUESTION # 30
Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

• A. Proposed product route and frequency of administration
• B. Immunochemical and functional tests
• C. Biological activity with species and/or tissue specificity
• D. Proposed dose and volume of administration

Answer: C
NEW QUESTION # 31
A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?

• A. Inform the authority that the time is not suitable and request a new time
• B. Arrange for an inspection without all intended personnel.
• C. Insist that key personnel be available for the inspection.
• D. Negotiate with colleagues and the authority to find a better time.

Answer: D
NEW QUESTION # 32
A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?

• A. No action is needed in this situation.
• B. Prepare regulatory submissions that detail the medical device's change in materials.
• C. Review the content of change and supporting data for the equivalency with the current material.
• D. Write a memo to file since the change does not impact product safety and effectiveness.

Answer: C
NEW QUESTION # 33
Which of the following claims would classify an apple as a drug?

• A. "It will satisfy hunger."
• B. "It will prevent colds."
• C. "It will make you look younger."
• D. "It will whiten teeth."

Answer: B
NEW QUESTION # 34
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