Do you submit reports to the FDA?

[Bari_sas]

If you submit reports created by SAS to the FDA, can you weigh in on the format you use? I am specifically curious if RTF or PDF is more common. If you use one over the other (ODS RTF/PDF), is it because of an FDA requirement for your field (and if so, can you point me to that requirement as a web link?), or because the formatting is easier to accomplish from SAS?

Thanks so much for your feedback!

[Lex_SAS]

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