All other serious, unexpected ADRs should be filed within how many calendar days after first knowledge?

• A. 7 calendar days.
• B. 30 calendar days.
• C. 15 calendar days.
• D. 60 calendar days.

Answer: (C)

In safety reporting, SUSARs (suspected adverse reactions) have expedited timelines that depend on severity. If a SUSAR is fatal or life-threatening, regulators must be informed within 7 calendar days of first knowledge. For all other serious but unexpected ADRs, the deadline is 15 calendar days from when first knowledge is obtained. The question uses the phrase “All other serious, unexpected ADRs,” which excludes fatal or life-threatening cases, so the 15-day window is the correct timeframe. This ensures timely communication of important safety information while allowing enough time to gather details. Options of 7, 30, or 60 days do not fit this category.