The DART pilot is getting ready to fly: Part 2

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 (FFU) pilot for SENDIG-DART. The view from the trenches …

The DART pilot is getting ready to fly

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 standard, and the FDA are going to run …

There is nothing permanent except change

“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, but it’s actually pretty common. I was reminded of …

SEND: Why did they have to make it so damn hard?!

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 like another? Yet, this SEND thing seemed so alien and impenetrable to …