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 before all of the information was available. Therefore, it would be the end of the workday before we could submit our responses. She asked us to submit the information we already had, and then send in a second submission later in the day with the remaining information.
In my experience, the FDA review divisions aren’t always up to speed with the latest procedures for eCTD submissions. Additionally, I was under the impression that the ESG would only accept once sequence per application per day. 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 multiple eCTD sequences in a day.
Thankfully, 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. We were able to get by with just one eCTD sequence, but it’s nice to know that we have the option of multiple eCTD sequences if we need to use it in the future!