1.4 — References

Letters of authorization, right of reference statements, and cross-references to other applications

Requirements by Phase

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

Content Requirements

• Letters of authorization from referenced application holders
• Right of reference statements
• List of authorized studies with study identifiers
• Cross-references to other INDs, NDAs, DMFs, or master files

Expected Deliverables

• Letters of authorization
• Right of reference statements
• Cross-reference list

ICH Guidelines: 21 CFR 312.23

Source: 21 CFR 312.23