A table of contents is defined by headings arranged in a hierarchical fashion.

See the associated specification, Comprehensive Table of Contents Headings and Hierarchy, for the comprehensive listing of headings and hierarchy. Because this is a comprehensive listing, not all headings are applicable to all submissions or submission types.

All of the information you need to submit is covered by these headings. If you think other headings are needed, you should contact our electronic submission coordinators prior to using any other headings.

Please also refer to the FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.