Navigating the New FDA Data Standards Catalog (2025 Update)

The FDA recently updated the Data Standards Catalog, and for clinical programmers, this is a significant shift...

Key Changes

The most notable update is the sunsetting of support for SDTMIG v3.2...

Impact on Define.xml

With the move to newer standards, Define.xml v2.0 is slowly being phased out...

What You Should Do Now

• Audit your current standard macro libraries.
• Review the "Support Ends" column in the catalog carefully.
• Start pilot submissions using Define-XML v2.1.