2.2 — CTD Introduction

Brief introduction to the drug including pharmacological class and proposed indication

Requirements by Phase

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

Content Requirements

• Proprietary (trade) name of the drug product
• Non-proprietary (generic/common) name or compound code
• Company name
• Dosage form(s) and strength(s)
• Route of administration
• Proposed indication(s)
• Pharmacological class

Expected Deliverables

• Introduction document (1 page max)

Page guidance: 1 page

ICH Guidelines: ICH M4

Source: ICH M4