Regulatory Submission Blog

Define.xml is often overlooked in nonclinical submissions, but with the right mindset and tools, it can become a powerful asset for regulatory review.

Lessons from the SENDIG-DART Fit-For-Use pilot reveal just how nuanced DART studies can be, especially when it comes to representing timing concepts like Gestation Day.

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.