General Resources For Formatting An IND
Templates, and examples organized by CTD module and section
| Resource Name | Description | Type | Source | Date Issued | Download |
|---|---|---|---|---|---|
| Comprehensive Table of Contents Headings and Hierarchy (eCTD v4.0) | eCTD v4.0 Comprehensive Table of Contents Headings and Hierarchy | Guidance | FDA | 01-Feb-2025 | |
| eCTD Specifications for File Format Types | Specifications for File Format Types Using eCTD Specifications | Guidance | FDA | 01-Feb-2025 | |
| FDA Regional eCTD v4.0 Module 1 Implementation Guide | FDA Module 1 Electronic Common Technical Document (eCTD) v4.0 Implementation Guide v1.7 | Guidance | FDA | 01-Jun-2024 | |
| Guidance for Industry M4: The CTD — General Questions and Answers | Guidance for Industry M4: The CTD — General Questions and Answers | Guidance | FDA | 01-Dec-2004 | |
| ICH eCTD v4.0 Implementation Guide | ICH eCTD v4.0 Implementation Guide | Guidance | External | 21-May-2024 | |
| M4E: The CTD — Efficacy | M4E(R2): The CTD — Efficacy | Guidance | FDA | 01-Jul-2017 | |
| M4E: The CTD — Quality | THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: QUALITY – M4Q(R1) | Guidance | External | 12-Sep-2002 | |
| M4S: The CTD — Safety | THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: SAFETY – M4S(R2) | Guidance | External | 01-Dec-2002 | |
| M4: The CTD — Organization | ORGANISATION OF THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE | Guidance | External | 15-Jun-2016 | |
| PDF Specifications | Portable Document Format (PDF) Specifications | Guidance | FDA | 01-Sep-2016 | |
| Technical Conformance Guide (eCTD v4.0) | eCTD v4.0 Technical Conformance Guide | Guidance | FDA | 01-Mar-2025 |