It’s likely that you’re already preparing a Development Safety Update Report (DSUR) for submission to regulatory authorities outside the US.  If so, you will be relieved to know that FDA adopted the ICH E2F Guideline.  This means that FDA will accept the DSUR to...

Pre-Assigned Application Number

Every eCTD application – whether it’s an ANDA, IND, BLA, DMF, or NDA – requires an application number.  In the days of paper submissions, FDA would assign an application number upon receipt, and then notify you after the fact.  In the eCTD world, the application...

Microsoft Word

The Problem For anyone upgrading from Microsoft Word 2003 to a newer version, there’s one annoying issue. The color we’ve all come to know as “hyperlink blue” is no longer one of the default options in the font color picker. With this color no longer a...

Recently, a client received a request from the review division at CDER to submit their Data Monitoring Committee (DMC) charter to the IND for review. The Problem There was some disagreement among our team about where to place this document in the eCTD structure.  The two competing...

Recently, a client needed to submit multiple responses before the end of the day. Without this information, FDA would be forced to delay a decision.  Unfortunately, it could take the client all day to prepare the responses. I let our RPM know that it might be late in the day...