Formatting and Submission Requirements (Tip Sheet)
Initial IND Application Templates
- Initial IND Application (body of application)
- Clinical Study Protocol (required section of the application)
- Chemistry, Manufacturing and Control Information (required section of the application)
- Pharmacology and Toxicology Information (required section of the application)
Required Reports
Other Submissions
- Protocol Amendment – New Investigator
- Protocol Amendment – New Protocol
- Protocol Amendment – Change in Protocol
- Information Amendment
- Change of Sponsor
- Change of Sponsor-Investigator