Regulatory Submission Blog

SEND may feel fast or slow depending on your perspective, but for those driving its progress, the pace can feel glacial despite years of dedicated effort.

At the recent CDISC SEND meeting, the FDA clarified that SEND is mandatory for applicable studies, regardless of factors like GLP status or eCTD section, reaffirming its critical regulatory value.

Ensuring alignment between the Study Tagging File and SEND datasets is now critical; miscommunication can lead to technical rejection, highlighting the need for better collaboration across teams.

With SEND enabling access to standardized data, the long-envisioned potential of Historical Control Data systems is becoming a practical reality.

The FDA’s latest guidance makes one thing clear: if a study informs clinical safety and can be rendered in SEND, it likely should be, making “Does this need SEND?” a tougher question than ever.

Much like Bez from the Happy Mondays, the Define-XML file may seem puzzling, but without it, the SEND package just isn’t complete, and its value is becoming harder to ignore.