Submitting a Monograph

Technical Information Requirements For Monograph Review 

Approved April 2014

Table of Contents

1. Foreword
   1. Minimum Standards
   2. Best Practices
2. Administrative
   1. Cover Letters
   2. Contact Information
   3. Presentation Content and Format
3. General Information
   1. Nomenclature
   2. Structure
   3. General Properties
4. Manufacture
   1. Manufacture(s)
   2. Description of Manufacturing Process and Process
   3. Control of Materials
5. Control of Drug Substance
   1. Specification
   2. Validation of Analytical Procedures
6. Reference Standards or Materials
   1. Non-official Reference Standards
7. Special Storage Conditions
   1. Special Storage Conditions
8. Stability
   1. Stability of Clinical Batches
9. Toxicology and Safety
   1. General Toxicological Requirements
10. Literature References
    1. Important Publications Referenced In The Report
11. Report Format and Content
    1. Title Page
    2. Introduction
    3. Table of Contents
    4. List of Abbreviations and Definition of Terms
    5. Content
12. References
    1. Regulatory References
13. Appendices
    1. Consolidated Monograph Review Checklist