The U.S. Food and Drug Administration (FDA) is exploring CDISC’s Dataset-JSON v1.1 as a new exchange standard for electronic study data submissions, with the long-term potential to replace the legacy SAS XPT format. This marks a major step towards modernizing regulatory submissions using machine-readable, flexible, and interoperable data formats.
The FDA is requesting public feedback on whether to accept Dataset-JSON for submissions to CBER and CDER, specifically seeking input on the benefits and risks of adopting Dataset-JSON. Read the full notice and submit your comments by 9 June 2025.
This is a significant milestone for CDISC and the broader clinical research community as we continue building a fully digital, standards-driven ecosystem. We encourage our partners, members, and stakeholders to share their perspectives.
View the full notice and submit comments here
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