Version 2.3.3. The Comprehensive Table of Contents Headings and Hierarchy . Revision History. Date Version Summary of Changes 2004-07 1.0 Original version
Electronic Common Technical Document (eCTD) v4.0 | FDA
Sep 19, 2024 · FDA eCTD v4.0 Implementation Status. CDER and CBER are accepting new regulatory applications in eCTD v4.0 format as of September 16, 2024. More information can be found on the eCTD page.
Comprehensive Table of Contents Headings and Hierarchy - Food …
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.
This eCTD Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit electronic Common Technical Document (eCTD)-based electronic ...
This document provides instructions on how the reader may be presented eCTD content in a viewing or display tool. The location of keywords on headings may be different than the assignment in the XML
The following tables describe the levels in the CTD/eCTD hierarchy at which documents/files should be placed and whether single or multiple documents are appropriate at each point. This
Resources - Food and Drug Administration
Aug 16, 2011 · Go to Specifications for Transmitting Electronic Submissions using eCTD Specifications; Guidance Documents . Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications (PDF - 132KB) (June 2008)
eCTD Specifications - Food and Drug Administration
Submit an eCTD sample prior to submitting an actual eCTD submission. Refer to the Comprehensive Table of Contents Headings and Hierarchy on the eCTD Web site, a link to which is located under the Resources tab.
• Web page for latest version of eCTD guidance, specifications, and validations • eCTD Comprehensive Table of Contents Headings and Hierarchy • M4 Organization of the Common Technical ...
eCTD v4.0 Comprehensive Table of Contents Headings and Hierarchy . Instructions to Reader . This document provides instructions on how the reader may be presented eCTD content in a viewing or