Introduction FDA’s March 2026 release of the Study Data Technical Conformance Guide (TCG v6.2) has been circulating for a few weeks now. For most teams, it reads like a routine update some language refinements, a few new sections, nothing that demands immediate attention. With the addition of Appendix I, that reading is worth revisiting. FDA’s expectations around SEND are shifting from technical compliance toward review readiness. Those are not the same thing, and the gap bet