by Marc Ellison | Apr 28, 2021 | Regulatory Submission, SEND, Sensible SEND
Does SEND include any skeuomorphs? Okay, strange word I know – stay with me….. Why does my phone make the sound of shutter when I take a photo? It doesn’t have a shutter, and even if it did, I wouldn’t be able to control its volume level. Yet, I hear that satisfying...
by Marc Ellison | Apr 14, 2021 | Regulatory Submission, SEND, Sensible SEND
Well, March 2021 turned out to be a big month in the world of SEND. The FDA issued their 90-day notice for the enforcement of the Technical Rejection Criteria (TRC) for Study Data. This means that the FDA will begin rejecting studies that don’t meet the criteria...
by Marc Ellison | Mar 31, 2021 | Regulatory Submission, SEND, Sensible SEND
SENDIG-DART v1.1 is currently supported by FDA, but not actually required, so should anyone really care? What’s the point of a standard that isn’t required yet? In this context, supported means that a sponsor could choose to include SEND datasets, and the FDA are...
by Marc Ellison | Mar 17, 2021 | Regulatory Submission, SEND, Sensible SEND
First, I noticed that I was getting a lot of email notifications and messages. More than usual. Something happened and the news was spreading. It was a Federal Register Notice (“FRN”) and it honestly came as a bit of a surprise. It was announcing that the FDA were...
by Marc Ellison | Mar 3, 2021 | Regulatory Submission, SEND, Sensible SEND
I know the title is the obvious cliché, but I had to do it. Sometimes things are obvious for a reason. I’ve just finished putting together my SOT/ToxExpo presentation and I’m still lamenting the fact that it’s virtual again this year. Anyway, as I alluded to in my...
