US FDA Updates to eSTAR (version 7.0) and preSTAR (version 3.0)
On June 1, 2026, the FDA released new major version for both eSTAR templates (version 7.0) and the PreSTAR template (version 3.0). These are major revisions to the templates meaning that after a transition period, the FDA expects all new submissions to be made using these versions of the templates.




