1.8 — IND Safety Reports

IND safety reports (Form 3500A) and follow-up safety reports per 21 CFR 312.32

Requirements by Phase

IND Phase 1: optional IND Phase 2: optional IND Phase 3: optional NDA: required

Content Requirements

• IND safety reports per 21 CFR 312.32
• 15-calendar-day alert reports for serious and unexpected suspected adverse reactions
• 7-calendar-day reports for fatal or life-threatening unexpected suspected adverse reactions
• Follow-up reports with additional information as it becomes available
• FDA Form 3500A (MedWatch) for each safety report
• Analysis of similar events and assessment of causality

Expected Deliverables

• FDA Form 3500A
• Follow-up safety reports
• Safety narrative

ICH Guidelines: 21 CFR 312.32

Source: 21 CFR 312.32