At a recent meeting of the NCRAF 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. In other words, it’s just a new sequence number filed under the IND. One person even heard this from an “expert” presenter at a recent medical writing conference.
Since there seems to be some confusion on this issue, a group member contacted FDA to get the official story. The CDER eSubmissions team, replied with the following information about the transition from IND to NDA:
- An eCTD NDA is not just a new sequence submitted under the IND number. An eCTD 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 OK 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.