October 25th, 2012
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. The two competing ideas were:
- Since this is a response to an FDA Request for Information, we should place it in Module 1.11.2 Safety Information Amendment.
- Since this is related to an open, active protocol, we should place it in Module 188.8.131.52 where the protocol was previously submitted.
January 23rd, 2012
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 Investigational Brochure (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.
My friend Missy Fussell of Allegro Solutions, Inc. recently faced this issue with one of her clients and posed the question to FDA. As usual, FDA’s Connie Robinson provided the following helpful response:
October 17th, 2011
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 might take until the end of the day to prepare.
I let our RPM know that it might be late in the day before all of the necessary information was available and therefore it would be close to the end of the workday before we could file a submission with our responses. She asked if I could go ahead and submit the information we already had in had, and then send in a second submission later in the day with the remaining information.
In my experience, the review divisions at FDA are not always up to speed with the latest procedures for eCTD submissions, and I was under the impression that the ESG will only accept once sequence per application per day. In fact, that “rule” was part of the institutional knowledge in my company. So, with the clock still ticking, I sent a quick email explaining the situation to the CDER eSubs team and asked whether or not we could submit more than one sequence in a day.
June 16th, 2011
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 discovered.
Prior to the upgrade, we used the “Create a PDF” button on the Acrobat toolbar in Word to create PDFs for submissions. As you know, PDFs created using this button will include functional bookmarks based upon the heading styles used, a fully hyperlinked table of contents, and functional internal hyperlinks within the text of the document (if they were created by the author). Shortly after the upgrade from Microsoft Office 2003 to Microsoft Office 2010, we noticed that the “Create a PDF” button was no longer functional in any Office application – nothing happened at all when we clicked it.
While our IT staff contacted both Microsoft and Adobe regarding this issue, my team began investigating workarounds to minimize the impact this would have on our publishing work. Unfortunately, we were only able to come up with two, less-than-stellar options.
June 1st, 2011
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.