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NEW QUESTION 20
The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in
Country Y?

• A. Prepare the legal team in Country Y for possible litigations.
• B. Initiate a mandatory recall of the product in Country Y.
• C. Draft a formal letter to customers in Country Y about this recall.
• D. Review alt distribution records and complaints reported in Country Y.

Answer: D

NEW QUESTION 21
A regulatory affairs professional has submitted a package for regulatory review.
According to the regulation, the regulatory authority will need to respond within 90 days of submission.
If there is no response after the deadline, what is the BEST approach?

• A. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
• B. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
• C. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.
• D. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.

Answer: A

NEW QUESTION 22
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 disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."
• B. "We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."
• C. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."
• D. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."

Answer: B

NEW QUESTION 23
Why is it necessary to run supplemental safety pharmacology studies?

• A. To substitute the utilization of GLP
• B. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
• C. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
• D. To comply with regulatory authority requirements related to clinical studies

Answer: C

NEW QUESTION 24
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