Regulatory Submission Blog

At the latest FDA–CDISC webcast, what wasn’t said about SEND scope may speak louder than what was, reinforcing the agency’s expectation for full compliance.

As SENDIG-DART v1.2 nears completion, CDISC teams prepare to expand SEND to better support juvenile toxicology studies, while work on SENDIG-GT and SEND 3.2 also accelerates.

Being “in the room where it happens” as a CDISC volunteer fuels my passion for SEND, because I truly believe in its power to improve drug safety and accelerate development.

FDA SEND feedback letters often cause panic, but 95% of the time, no action is required. They’re meant to guide future improvements and help raise industry standards.

March marks the countdown to new FDA SEND requirements, including SEND 3.1.1, SENDIG-DART 1.1, and Define-XML 2.1—organizations have 12 months to prepare.

Guest contributor, Christy Kubin from Charles River Laboratories, shares her thoughts on SEND Conformance Rules.