Electronic Study Data Submission; Data Standards; Support for Standard for Exchange of Nonclinical Data Implementation Guide Version 3.1

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is announcing support for the 3.1 version of Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data (SEND IG 3.1), the end of support for the 3.0 version of SEND IG, and an update to the FDA Data Standards Catalog (Catalog). (See http://www.fda.gov/forindustry/ datastandards/studydatastandards/default.htm.) SEND IG 3.1 has been available from CDISC (www.cdisc.org) since July 2016. FDA is encouraging sponsors and applicants to use SEND IG 3.1 in investigational study data provided in regulatory submissions to CDER.