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NEW QUESTION 29
A company is developing a new medical device. During which initial stage is it MOST appropriate (or a
regulatory affairs professional to become involved?
Answer: D
NEW QUESTION 30
During routine surveillance, a regulatory authority sent a company the following communication:
"Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product.
The regulatory authority is evaluating these issues to determine the need for any regulatory action."
Which action would be the most appropriate FIRST step for the company to take?
Answer: D
NEW QUESTION 31
In which section of the ICH Common Technical Document will the overview of clinical data appear?
Answer: D
NEW QUESTION 32
......
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