This demonstration software is intended to allow persons to help CDER develop and test the utility of using an XML based CTOC in our electronic document room (EDR). The FDA is committed to the negotiation process within the Internation Converence on Harmonization (ICH) as described in the document at the following hyperlink:
A document is available that better describes the demonstration software and how to use it:
The tool is packaged as a zip file that inludes the working model download, TOCeditor, Link validator and documentation that specifies the XML file formats and contents. Place the zip file in an empty folder and extract it. You will find a small folder system with other Read_Me files and other zip files. Follow the instructions as you come to them.
Other public presentions by Office of New Drug Chemistry staff are available at:
Thank you