by Marc Ellison | Dec 2, 2020 | Regulatory Submission, SEND, Sensible SEND
In Part 1, I went into the detail of what the new SENDIG-DART standard covered; and now I’ll conclude by describing what’s involved in ensuring the industry is equipped with the necessary tools and services in order to successfully participate in the FDA’s Fit For Use...
by Marc Ellison | Nov 18, 2020 | Regulatory Submission, SEND, Sensible SEND
It’s here. It’s finally here. It’s actually real. This is going to happen. This is part 1 of a 2 part mini-series, hang in there… I’m referring to the FDA Federal Register Notice for the pilot of SENDIG-DART (that’s SEND for Reproductive Tox). It’s a new SEND...
by Marc Ellison | Nov 4, 2020 | Regulatory Submission, SEND, Sensible SEND
“There’s a saying around here: If you don’t like the weather… wait 10 minutes!”. Pre-COVID, I was fortunate that my work allowed me to travel, and especially around the US. This is a phrase I’ve heard several times and everyone thinks it’s unique to their area,...
by Marc Ellison | Oct 21, 2020 | Regulatory Submission, SEND, Sensible SEND
In my previous blog, I recalled the tale of my first experience with SEND. I’d assumed that standardizing nonclinical data would be straightforward, after all we have standard glossaries and lexicons from the likes of INHAND, and isn’t one 28-day study pretty much...
by Marc Ellison | Oct 7, 2020 | Regulatory Submission, SEND, Sensible SEND
Hi and welcome, I’m Marc and I’m a SEND nerd. I’ve been a SEND nerd for 8 years, 3 months and 22 days. The last time I referred to the SEND Implementation Guide was 2 hours and 16 minutes ago. This is what my life has become. That is what SEND does to you, and I can’t...
