Regulatory Submission Blog

Despite being a standard, SEND’s flexibility means everyone does it slightly differently, making it a “subjective standard” in practice.

In a digital world where speed is expected SEND still takes time, because quality, compliance, and subjective interpretation demand more than just pressing “convert.”

SEND sometimes mimics reported data rather than collected data – like a digital camera’s fake shutter sound mimics the real thing – raising the question of whether these “skeuomorphs” belong in our datasets or not.

March 2021 was huge for SEND – with FDA enforcing Technical Rejection Criteria, releasing new guidance, and CDISC publishing updates.

“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.