FDA Urges Drugmakers to Change to New Data Format

The FDA only will accept clinical trial data submissions in an upgraded format starting in March 2018.

Companies are urged to upgrade to Version 2.0 of the Clinical Data Interchange Standards Consortium Case Report Tabulation Data Definition, or Define.xml, due to its enhanced capabilities and reorganization of data sets.

After March 15, 2018, CDER and CBER will no longer accept data submissions using Version 1.0, the FDA said in a Federal Register notice. It has accepted data in this format since 2004.

A December 2014 guidance document warned of Version 1.0’s eventual demise, pushing companies to use Version 2.0 for future data submissions accompanying NDAs, ANDAs, BLAs and INDs, but did not set a date.