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NEW QUESTION 44
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 45
Which of the following is NOT required to be included in a marketing application?
Answer: C
NEW QUESTION 46
In which section of the ICH Common Technical Document will the overview of clinical data appear?
Answer: A
NEW QUESTION 47
During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?
Answer: B
NEW QUESTION 48
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
Answer: B
NEW QUESTION 49
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