Intel, insight and opinions from SEND Specialist (Nerd), Marc Ellison

Welcome to Sensible SEND 

We hope you’ll bookmark the blog and check back often. Look for new posts every other Wednesday offering insights and expert opinions to help you navigate the challenges and opportunities that arise from the SEND standard.

So, what did we learn from the FDA’s DART Fit For Use Pilot?

For most organizations, the FDA’s SENDIG-DART v1.1 Fit-For-Use (FFU) pilot started with the Federal Register notice being posted back in October 2020. For some of us it began earlier when it became apparent that the FDA had an appetite to adopt the SEND standard for Developmental and Reproductive Toxicology (DART). That meant a pilot was …

Silence speaks volumes

In my last posting, we were talking about the CDISC working conference where I mentioned that one of the highlights of the week was the FDA public webcast. In the past, sometimes these have included surprising announcements which have generated a flurry of activity as we all try to digest and respond to the latest …