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NEW QUESTION 35
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: B
NEW QUESTION 36
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
Answer: A
NEW QUESTION 37
A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company's products. What action should the company take FIRST?
Answer: B
NEW QUESTION 38
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