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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q20-Q25):

NEW QUESTION # 20
As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?

• A. Delay the start of product production.
• B. Inform the regulatory authorities.
• C. Correct the label text.
• D. Abort the product launch.

Answer: B
NEW QUESTION # 21
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

• A. Site license
• B. Export license
• C. Import license
• D. Product license

Answer: A
NEW QUESTION # 22
At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

• A. Regulatory agency
• B. Quality assurance
• C. Clinical affairs
• D. Quality improvement

Answer: B
NEW QUESTION # 23
Which of the following statements regarding the off-label use of drugs is CORRECT?

• A. 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.
• B. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.
• C. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
• D. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.

Answer: C
NEW QUESTION # 24
One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority's request?

• A. "We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."
• B. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."
• C. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."
• D. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."

Answer: A
NEW QUESTION # 25
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