Scanned Documents

Scanned documents are a pain point for eCTD publishers and FDA reviewers alike. No one likes them, but, unfortunately, we all have to deal with them. In their “Portable Document Format (PDF) Specifications,” FDA attempts to minimize the inconvenience of scanned documents...

ESG Accounts

Good news from FDA! On 25 July 2016, FDA announced that CROs and consultants are no longer required to register separate ESG accounts for each client. You are now only required to have one ESG account for submissions for all clients. This policy change is the latest of several...

chalkboard

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...