In the "Guidance for Industry Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications" (U.S. Department of Health and Human Services Food and Drug Administration;
http://www.fda.gov/cder/guidance/7087rev.pdf) in the File Formats section, these are the formats mentioned:
- PDF for reports and forms
- SAS XPORT (version 5) transport files (XPT) for datasets
- ASCII text files (e.g., SAS program files, NONMEM control files) using txt for the file extension
- XML for documents, data, and document information files
- Stylesheets (XSL) and document type definition (DTD) for the XML document information files
- Microsoft Word for draft labeling (because Microsoft Word can change, check our Web site for the current version)
Hope this helps,
Lex Jansen