Regulatory teams are under more pressure than ever to submit clean, review-ready data. SEND has been mandatory for CDER nonclinical studies since 2017. Enforcement of Technical Rejection Criteria has been active since September 2021. By now, you would expect most submissions to be arriving at FDA without structural errors. The data says otherwise. Three years into active TRC enforcement, SEND continues to account for the majority of errors across every rejection code FDA trac

Key stages influencing SEND readiness and where challenges typically arise Introduction With SEND now required for U.S. FDA submissions, its role extends beyond dataset creation and directly influences submission quality, review efficiency, and regulatory confidence. However, achieving SEND readiness is often more complex than anticipated. What appears to be a structured, standards-driven process can become challenging in practice particularly across diverse studies, systems,