Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I'm trying to find an old guidance, comprehensive table of contents or similar that maps the legacy FDA NDA/BLA "Item" table of contents into the CTD table of contents structure and contains the Item/Section numbering for Item level tocs.

I have the Comprehensive Table of Contents which maps the CFR citation to the CTD format --- but I'm looking for something with the legacy "Item/Section" numbering which goes beyond the level 1 headings.  

Any direction is appreciated. 

Thanks in advance.

This guidance may be of help, although I don't think it is the exact one you are looking for:   
https://www.fda.gov/media/76482/download

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Bridgette Kunst MA, RAC
Managing Director
Bridge Regulatory Affairs, LLC
bkunst@bridgereg.com
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Original Message:
Sent: 24-May-2019 10:02
From: Anonymous Member
Subject: Mapping of legacy FDA NDA/BLA Format to CTD - circa 2001

This message was posted by a user wishing to remain anonymous

I'm trying to find an old guidance, comprehensive table of contents or similar that maps the legacy FDA NDA/BLA "Item" table of contents into the CTD table of contents structure and contains the Item/Section numbering for Item level tocs.

I have the Comprehensive Table of Contents which maps the CFR citation to the CTD format --- but I'm looking for something with the legacy "Item/Section" numbering which goes beyond the level 1 headings.

Any direction is appreciated.

Thanks in advance.