Regulatory Submission Blog

“Supported but not required” isn’t just a status, it’s a warning. Now’s the time to prepare for SENDIG-DART v1.1 before it becomes mandatory.

The FDA’s surprise Federal Register Notice makes SENDIG-DART officially accepted, and required from March 2023. For those of us who’ve championed it, it’s a long-awaited and exciting milestone.

Standardized SEND data is unlocking the power of visualization, enabling faster, clearer insights and opening the door to a future beyond static PDFs.

While many still struggle with SEND, a few are venturing Beyond Compliance, unlocking insights from standardized data with tools like SEND Explorer and breathing new life into legacy studies.

SEND doesn’t yet support Anti-Drug Antibody data, and while custom domains offer a solution, most of the industry isn’t ready, leaving experts like Marc caught between progress and practicality.

SEND was once “just an electronic study report” but today, it’s clear that SEND often goes beyond the report, with data collection and presentation shaped by the standard itself.