The FDA’s SENDIG-DART pilot is finally here! This new SEND standard covers Embryo-Fetal Development studies with 7 new domains, building on SEND 3.1. It’s been a long journey from development to this pilot – exciting...
SEND keeps changing fast. Recently, FDA made it clear that SEND requirements go beyond just studies placed in the eCTD, if a study can be represented in SEND, it should be. This broadens the scope...
At first, I thought SEND would be simple, just standardizing study data like any other. But it’s far more complex, involving multiple overlapping standards, evolving regulations, and even clinical concepts awkwardly adapted for nonclinical use....
Hi, I’m Marc, a SEND nerd for over 8 years. My first SEND meeting was like learning a new language, but I quickly got hooked. Now I blog about the challenges and future possibilities of...
