Ask CATO: Pre-IND Submissions in eCTD Format

Historically, we made our Pre-IND submissions in paper (e.g., Pre-IND meeting request, briefing package, and meeting minutes) and we began using eCTD format with the initial IND submission. However, since FDA assigns a Pre-IND number, which ultimately becomes the IND number, and Module 1 includes at least two places that are appropriate for including Pre-IND documents (either Module 1.12.1 or Module 1.6 for meeting-related documents), we should be able to make these submissions in eCTD format as well. Doing so would allow us to ease into the use of eCTD format, which would be especially useful when working with sponsors who are new to the eCTD format.

So, I recently asked the CDER Electronic Submissions team if it is possible to make Pre-IND submissions in eCTD format. As usual, I received a quick and helpful reply to my query, this time from Regulatory Information Specialist Valerie Gooding.

“Yes, it is possible to submit Pre-IND correspondence in eCTD format.”

She noted that the submission type in the Regional Metadata should be set to “Presubmission,” for any Pre-IND submissions. The initial IND that eventually follows follows should be set as the “Original Application,” regardless of the sequence number.

She confirmed that all Pre-IND meeting-related correspondence should be included in the appropriate Module 1.6 subsections instead of Module 1.12.1

To find more information click here: Ask CATO: Pre-IND Submissions in eCTD Format