23 January 2012

ECTD Tips: How to Submit a Development Safety Update Report (DSUR) to FDA in an eCTD IND

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 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.

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