https://communities.sas.com/t5/ODS-and-Base-Reporting/Do-you-submit-reports-to-the-FDA/m-p/17439#M3542 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; <A href="http://www.fda.gov/cder/guidance/7087rev.pdf)" target="_blank">http://www.fda.gov/cder/guidance/7087rev.pdf)</A> in the File Formats section, these are the formats mentioned:<BR /> <BR /> - PDF for reports and forms<BR /> - SAS XPORT (version 5) transport files (XPT) for datasets<BR /> - ASCII text files (e.g., SAS program files, NONMEM control files) using txt for the file extension<BR /> - XML for documents, data, and document information files<BR /> - Stylesheets (XSL) and document type definition (DTD) for the XML document information files<BR /> - Microsoft Word for draft labeling (because Microsoft Word can change, check our Web site for the current version)<BR /> <BR /> <BR /> Hope this helps,<BR /> Lex Jansen Tue, 13 May 2008 14:17:55 GMT Lex_SAS 2008-05-13T14:17:55Z https://communities.sas.com/t5/ODS-and-Base-Reporting/Do-you-submit-reports-to-the-FDA/m-p/17438#M3541 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?<BR /> <BR /> Thanks so much for your feedback! Mon, 12 May 2008 18:50:19 GMT https://communities.sas.com/t5/ODS-and-Base-Reporting/Do-you-submit-reports-to-the-FDA/m-p/17438#M3541 Bari_sas 2008-05-12T18:50:19Z https://communities.sas.com/t5/ODS-and-Base-Reporting/Do-you-submit-reports-to-the-FDA/m-p/17439#M3542 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; <A href="http://www.fda.gov/cder/guidance/7087rev.pdf)" target="_blank">http://www.fda.gov/cder/guidance/7087rev.pdf)</A> in the File Formats section, these are the formats mentioned:<BR /> <BR /> - PDF for reports and forms<BR /> - SAS XPORT (version 5) transport files (XPT) for datasets<BR /> - ASCII text files (e.g., SAS program files, NONMEM control files) using txt for the file extension<BR /> - XML for documents, data, and document information files<BR /> - Stylesheets (XSL) and document type definition (DTD) for the XML document information files<BR /> - Microsoft Word for draft labeling (because Microsoft Word can change, check our Web site for the current version)<BR /> <BR /> <BR /> Hope this helps,<BR /> Lex Jansen Tue, 13 May 2008 14:17:55 GMT https://communities.sas.com/t5/ODS-and-Base-Reporting/Do-you-submit-reports-to-the-FDA/m-p/17439#M3542 Lex_SAS 2008-05-13T14:17:55Z