Posts Tagged ‘Annual Report’

How to Submit a DSUR to 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 […]