Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

We're in the process of doing our first Annual IND Report and wanted to know whether it can be submitted as one document or does each section need to be separate? It will be submitted electronically as an eCTD sequence. 

Thanks for your help.

Hello,

The separate sections included in annual reports are delineated with individual eCTD headings under 1.13 - see FDA's "The Comprehensive Table of Contents Headings and Hierarchy" document, Module 1 for more information. I have always submitted them separately, in accordance with recommendations from several different eCTD publishers.

A good way to organize the contents of annual report submissions is to provide a table of the individual sections included in the submission as part of the submission cover letter. If there are no updates to report in some sections, they can be "N/A" in the table, and omitted from the submission.

Hope this helps!

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Marshall Hoke
Director of Regulatory Affairs
Lafayette CO
United States
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Original Message:
Sent: 17-Aug-2021 13:15
From: Anonymous Member
Subject: Annual IND Report

This message was posted by a user wishing to remain anonymous

Hello,

We're in the process of doing our first Annual IND Report and wanted to know whether it can be submitted as one document or does each section need to be separate? It will be submitted electronically as an eCTD sequence.

Thanks for your help.

Hi,

You may want to explore the center's requirements, but CDER expects you to upload individual documents; a cover letter, Form 1571, an annual report, and other documents.  As suggested by Marshall, the annual report should contain a detailed "Table of Contents."  This is very crucial.

For CBER, I have combined all the above documents as a PDF and email them to CBERDCC_eMailSub@fda.hhs.gov.

I hope this helps.

Israr

------------------------------
Israr Ansari PhD, MS, RAC
Sr. Scientist - Clinical Trials
University of Wisconsin-Madison
Madison, WI.
USA
------------------------------

Original Message:
Sent: 17-Aug-2021 13:15
From: Anonymous Member
Subject: Annual IND Report

This message was posted by a user wishing to remain anonymous

Hello,

We're in the process of doing our first Annual IND Report and wanted to know whether it can be submitted as one document or does each section need to be separate? It will be submitted electronically as an eCTD sequence.

Thanks for your help.