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.

The following links provide information on using the SAS XPORT transport format to submit data sets to the FDA. Specifications for the XPORT format are provided in TS-140 so that it is not necessary to use SAS software to translate data sets to/from this format.

• 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) 

• SAS System Viewer Included in FDA Guidance Recommendations

• The Electronic Records; Electronic Signature Rule
  

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