FDA and SAS Technology

The FDA is defining standards for various types of electronic submissions to the agency. A transport format developed by SAS Institute has been adopted as an FDA standard for accepting and archiving data sets.

• FDA Standards for Electronic Submissions

• Q&A: The SAS XPORT Transport Format as an FDA Standard for Data Sets

• Code for Processing Data Sets to/from the Transport Format

• The Record layout of a Data Set in SAS XPORT Transport Format (TS-140)

• FDA Guidance Documents
  (When you get to the Web page, click on "Electronic Submissions" on the left-hand side of the page.)

• SAS System Viewer Included in FDA Guidance Recommendations

• The Electronic Records; Electronic Signature Rule
  

To request more information, please contact Jeff.Mudd@sas.com.