FDA Issues Four Documents on Format For Electronic Regulatory Submissions

The Food and Drug Administration announced the availability of revised final versions of four documents about making regulatory submissions using the electronic Common Technical Document (eCTD) format, according to a notice published May 15 in the Federal Register (79 Fed. Reg. 27,872).

The four documents are:

• the eCTD Backbone Files Specification for Module 1, version 2.3 (which includes the U.S. regional document type definition (DTD, version 3.3);
• the Comprehensive Table of Contents Headings and Hierarchy, version 2.3;
• Specifications for eCTD Validation Criteria, version 3.1; and
• Example Submissions using eCTD Backbone Files Specification for Module 1, version 1.3.

The agency said ...