Submitting eCTD in Advance of a Milestone Application

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While advanced GPS systems and the advent of Big Data analytics are negating some of their advantages, early birds are still capturing worms at a good clip. We’ve heard this slogan since childhood. For those of you planning to implement eCTD, the early bird’s experience rings true.

Many people erroneously believe that your first eCTD submission is restricted to a major milestone application – Investigational New Drug (IND) application, Biologics License Application (BLA) or New Drug Application (NDA). That’s simply not the case. It’s 100% possible to file pre-NDA meeting requests, meeting packages and meeting minutes via eCTD in advance of the original NDA submission.

The first step in the process is asking the FDA to assign an application number. It’s a straightforward process that only requires an exchange of emails. Typically sponsors hear back in less than a week. Complete instructions for Requesting a Pre-Assigned Application Number are available online at the FDA.

Once the FDA replies with the application number, you’re ready to go. Planning to submit a meeting request in eCTD format is an excellent opportunity to establish a line of communication with your assigned FDA Regulatory Project Manager (RPM).

If you’re filing in advance of an IND, set the submission sub-type as presubmission. The inclusion of electronically-signed, FDA sanctioned fillable forms (e.g., 1571 or 356h) enables automated submission processing. Pre-IND meeting communications are placed in Module 1, specifically section 1.12.1. Likewise, a pre-NDA/BLA meeting request is handled in a similar fashion – eCTD format and sent via the Electronic Submission Gateway (ESG). Again, this type of meeting is another excellent opportunity to establish a positive working relationship with your RPM.

Early birds who take initiative and file pre-milestone submissions in eCTD format have extra time to get acquainted with the intricacies of the standard and an additional opportunity to learn. There is nothing worse than playing “catch up”, especially with the eCTD mandate looming.

Author: Rob Labriola

Rob Labriola has 20 years experience in regulatory operations for the pharmaceutical industry. Mr. Labriola has seen it all and truly understand the frustrations and rewards of moving to eCTD. He has worked on multiple application types (INDs, NDAs, BLAs, CTAs, NDSs, JNDAs and MAAs), and has extensive international experience, having submitted applications to the FDA, Canada, Europe, Switzerland, Australia, Israel, Japan, etc.

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