1.9 — Annual Reports

IND annual reports per 21 CFR 312.33 summarizing study progress, safety, and manufacturing changes

Requirements by Phase

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

Content Requirements

• Brief summary of status of each study in progress and each study completed (number of subjects enrolled, demographics)
• Summary of the most frequent and most serious adverse experiences by body system
• Summary of all IND safety reports submitted during the reporting period
• List of subjects who died during participation and cause of death
• List of subjects who dropped out due to adverse experiences
• Brief description of any informational amendments submitted
• Brief description of any significant manufacturing changes
• Description of any significant new investigational plan
• Summary of any significant foreign marketing developments
• Log of any outstanding business with FDA

Expected Deliverables

• Annual report document

ICH Guidelines: 21 CFR 312.33

Regulatory Requirements (FDA IND PHASE 1)

• [Phase 1] Modifications of the experimental design of Phase 1 studies that do not affect critical safety assessments are required to be reported to FDA only in the IND annual report.

Source: 21 CFR 312.33