As mentioned in my last post, at the DIA Annual Meeting in Boston at the end of June, the FDA announced that the implementation of the long awaited new eCTD Module 1 would be delayed until June 2014. The FDA has now released 4 guidance documents for vendors and industry to prepare for the new Module 1:
- The eCTD Backbone Files Specification for Module 1 (v2.2)
- The Comprehensive Table of Contents Headings and Hierarchy (v2.2)
- Specifications for eCTD Validation Criteria (v3.0) and
- Example Submissions using the eCTD Backbone Files Specification for Module 1 (v1.2)
There are many advantages for migrating eCTDs to the new Module 1 format. 515 Consulting Group uses EXTEDO’s eCTDmanager to prepare and publish eCTD submissions to the FDA and other Authorities around the world and since we will want to migrate our client’s eCTDs when the time comes, we asked Karteek Sandadi, Professional Services Manager for EXTEDO in North America when eCTDmanager will support the new M1 functionality. We were pleased to learn that EXTEDO plans to support the new FDA M1 functionality in eCTDmanager in the Q1 2014 timeframe. We look forward to trying it out.