eCTD Tips

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.

Thankfully, Regulatory Information Specialist Connie Robinson responded to my query within a few minutes.  She confirmed that you can submit multiple eCTD sequences in one day to a single application and that there is no limit to the number of sequences that you can submit.

In the end, all of the necessary information was available earlier than expected, and we were able to get by with just one eCTD sequence, but it’s nice to know that we have the option of multiple submissions if we need to use it in the future!

Related articles:

• Transitioning from Paper to eCTD (theectdsummit.com)
• Health Canada Increases Acceptance of eCTD Electronic-only Filings (ask-cato.com)