3.2.A.3 — Novel Excipients

Safety data package for novel excipients

Requirements by Phase

IND Phase 1: conditional IND Phase 2: conditional IND Phase 3: conditional NDA: conditional

Content (NCE/Small Molecule)

• Full details of manufacture of novel excipient (as per drug substance format)
• Characterization and control data for novel excipient
• Cross-references to supporting nonclinical and clinical safety data

Expected Deliverables

• Novel excipient manufacturing description
• Novel excipient characterization report
• Novel excipient specification
• Safety data cross-references

Note: If novel excipient used

Source: FDA Novel Excipient Guidance