After reporting a fatal or life-threatening ADR within 7 days, by when should a more complete report typically be provided?

• A. Within 8 additional calendar days.
• B. Within 15 calendar days.
• C. Within 30 calendar days.
• D. Within 60 calendar days.

Answer: (A)

When a fatal or life-threatening adverse drug reaction is identified, there are two steps for reporting. The event is reported promptly within 7 calendar days of awareness, and then a more complete description is submitted within 8 additional calendar days. That means the follow-up report is due 8 days after the initial notification, for a total of 15 calendar days from awareness. This two-step process balances urgent safety communication with the need for more detailed information to evaluate causality and risk.