Recently, I was working with a sponsor who received a request from the review division at CDER to submit their Data Monitoring Committee (DMC) charter to the IND for review.  There was some disagreement among our team about where to place this document in the eCTD structure. ...

Question

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...

Image by Joel Bez (via Flickr)

I recently encountered a situation in which a sponsor needed to provide responses to multiple Information Request Letters to FDA before the end of the day in order for FDA to meet a decision deadline.  Unfortunately, some of the responses were immediately available, while others...

Word 2010

In a previous post, I discussed a minor issue that we encountered when my company recently upgraded from Microsoft Office 2003 to Microsoft Office 2010.  In this post, I’ll describe a more serious problem caused by the update and the (relatively) easy solution we finally...

I’ve written a post today on the Ask Cato blog discussing the recent changes announced by Health Canada concerning their acceptance of eCTD submissions.  Head over there for the full story. Share this:EmailTwitterLinkedInFacebookPocketMorePrintGoogleRedditPinterestTumblr...