As large amount of documentation and data are required in IND submissions, the Electronic Common Technical Document (eCTD) format is a wise choice for the submission of INDs to the FDA. Camargo’s experience with filing INDs in the eCTD format includes a very recent eCTD IND application accepted by the FDA’s Division of Anesthesia, Analgesia & Rheumatology Products (DAARP).
Because submission of eCTD INDs requires an e-CTD software package, keep in mind that several versions are available from different vendors. Although applicants can use many different approaches to filing an eCTD IND, Camargo strategy in filing eCTD INDs involves the following steps:
- Documents are written in Microsoft WORD files using templates based on ICH eCTD guidances;
- PDF documents created from the WORD documents mentioned above;
- The PDF documents are loaded onto an XML backbone
- Once finished loading the files, the software validates the XML files including backbone and Study Tagging File against DTD format guidelines and allows the entire application to be exported as a submission.
- The resulting document submission can then be burned to a CD. It is important to note that not all CD burner software work may work properly when handling these files.