At a recent meeting of the North Carolina Regulatory Affairs Forum‘s eCTD Group, I learned that several of my colleagues there have fielded questions from clients who believed that an eCTD NDA is just an extension of the IND, i.e., it’s just a new sequence number that is filed under the IND number. One group member, a medical writer, even heard this from an “expert” presenter at a recent medical writing conference.
Since there seems to be some confusion on this issue, another group member contacted FDA to get the official story straight from the horse’s mouth. Valerie Gooding, a Regulatory Information Specialist on the CDER eSubmissions team, replied with the following information about the transition from IND to NDA:
- An NDA is not just a new sequence submitted under the IND number. An NDA is an entirely new application, with its own application number.
- If a sponsor does not wish to resubmit information from the IND in the NDA, it is acceptable for a sponsor to cross reference information.
I’ll follow up in future posts with more information about how to request a new application number and about how to cross reference between applications.
- Free Webinar – FDA Review Process for eCTD Submissions (ask-cato.com)
- Top Reasons to Adopt eCTD Viewing Software (ask-cato.com)
- Hyperlinking Do’s and Don’ts (theectdsummit.com)