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NEW QUESTION: 1
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: 2

A. Option A
B. Option C
C. Option D
D. Option B
Answer: B,D

NEW QUESTION: 3
Click the Exhibit button.

Where should you click to make Video 1 your target track?
A. A
B. B
C. C
D. D
Answer: C