By now, you’ve heard of FDA’s planned updates for Module 1. Among these is a new section heading, 1.13.15, for the Development Safety Update Report (DSUR). This is great news for those of you who are already preparing and submitting these reports in the EU, but FDA’s Module 1 update is not expected to be implemented until early 2013.
So, how should you submit a DSUR to an eCTD IND within the current Module 1 structure? A number of the items in the DSUR overlap with items in the US Annual Report. These items already have specific, reserved sections within section 1.13 and are normally submitted as standalone documents. Also, the Investigational Brochure (IB) is listed as an Appendix in the DSUR, but according to the current US Module 1 specification, the IB should be placed as a standalone document in section 1.14.4. It’s not clear whether FDA now expects to receive all of these items merged into one single document (the DSUR) or not.
My friend Missy Fussell of Allegro Solutions, Inc. recently faced this issue with one of her clients and posed the question to FDA. As usual, FDA’s Connie Robinson provided the following helpful response:
Currently for an IND, it would be acceptable to place the DSUR as a single document in 1.13.3 Summary of Safety Information. You should state that the DSUR is being submitted in place of the IND annual report in the cover letter and provide a link to the document if possible.
If information (other than the granular annual report information) is expected as a part of the DSUR, but the information has its own designated eCTD location, the information should be placed in its own designated eCTD location. For example the IB should be placed in Module 188.8.131.52 and you should provide reference links from the DSUR’s Appendix 1 and the DSUR TOC rather than including it as an appendix in the DSUR.
Connie also noted that more information about the DSUR would be forthcoming along with the implementation of the updates to Module 1.
Thanks for sharing this information Missy!
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