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NEW QUESTION 45
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

• A. Inform the regulatory authority that such a requirement is not applicable to the product.
• B. Inform the internal departments to redesign the product to comply with this requirement.
• C. Notify senior management that the product cannot be registered.
• D. Discuss with the regulatory apriority and attempt to reach an acceptable solution.

Answer: D

NEW QUESTION 46
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. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."
• 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. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."
• 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 47
A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy.
The product is marketed in Country X.
where it is regulated as a medical device.
The same product, without the antibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?

• A. Submit the product for review as a pharmaceutical product in Country Y.
• B. Examine decisions made about similar products in Country Y to propose the classification of the product.
• C. Apply for review of the additional part of the product as a pharmaceutical product in Country
• D. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.

Answer: C

NEW QUESTION 48
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