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NEW QUESTION 20
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?

• A. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
• B. Contact the regulatory authority to discuss its findings.
• C. Wait for the regulatory authority's final publication on its findings.
• D. Contact the regulatory authority to argue that its conclusions are wrong.

Answer: B

NEW QUESTION 21
As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?

• A. Correct the label text.
• B. Abort the product launch.
• C. Delay the start of product production.
• D. Inform the regulatory authorities.

Answer: D

NEW QUESTION 22
Which of the following double-blind clinical trial designs would be MOST appropriate for a
Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?

• A. Cross-over
• B. Placebo-controlled
• C. Dose-ranging
• D. Active-controlled

Answer: A

NEW QUESTION 23
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