Definition

An expedited safety report submitted within 15 calendar days for serious, unexpected adverse reactions from post-marketing spontaneous sources.

Example

Day 0: Company becomes aware of serious unexpected hepatotoxicity from a spontaneous report. Day 15 (or earlier): ICSR must be submitted to FDA and other relevant authorities.

Regulatory source

21 CFR 314.80, ICH E2D

Common mistakes

Waiting until Day 15 to submit when information is complete earlier. Regulations require submission 'as soon as possible but no later than 15 days.'

Inspector question

What is your average submission time for 15-day reports? Show me your compliance metrics.

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