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 adopting SENDIG-DART and stating they would start to require it for submission. As a reminder, SENDIG-DART is the SEND Standard for Development and Repro tox, and if you’ve been following this blog, then you are well aware that it’s one of my favorite topics to discuss.
The FRN states that FDA will begin to accept SENDIG-DART in submissions from 15th March. That’s March 15th of this year. No, I couldn’t believe it either. It will become an actual submission requirement from March 2023; but that’s only 2 years away. FDA are actually accepting it now – but no doubt with their usual “strongly encourage the use of” tag. Also, yesterday the FDA’s Data Standards Catalogue was updated to add SENDIG-DART, reflecting the details in the FRN.
Regular readers will know that I was part of the team that wrote the SENDIG-DART, so seeing it being accepted by FDA and seeing a date for when the requirement will kick in, is huge. This came just a week after the closing date for organizations to register their application to participate in the FDA’s Fit For Use pilot of the SENDIG-DART.
We actually published the standard back in 2017, and since that time it’s been patiently waiting for its turn in the FDA spotlight. Obviously, this didn’t come completely out of the blue. We’ve been hearing noises from FDA for the past year about the desire for a Fit For Use pilot, but I have to admit that the date of March 15th took me by surprise. And I’m delighted. This is a full year ahead of what I was expecting. As regular readers will also know, with the anticipation of the pilot, I’ve been busy developing our tools and services to support DART, so while surprised, we are prepared.
While we are on the topic of DART and completely coincidentally, I’ve changed my role at CDISC. Again, regular readers may well recall that I was leading the PC/PP team developing the Pharmacokinetics domains. Well, this this week, I have handed that team over to a new leader, as I’m now the new team lead for the DART subteam. So, I’ll be leading the team in developing the next version of the SENDIG-DART which will focus on widening the scope to include Juvenile Tox studies.
What else is going on in March? Well, SEND 3.1.1 will be released from CDISC! This sees the PC/PP team’s hard work finally published. This month we also expect that the FDA will publish the next update to the Technical Conformance Guide. It will be fascinating to see their latest changes. Will it incorporate any updates driven by CBER?
And we also have the SOT/Tox Expo. For many of us, the biggest event of the year. I can’t think of SOT without lamenting the fact that this year again it’s virtual. Yesterday, as part of SOT, I delivered an online presentation looking at the some of the key issues organizations are grappling with at the moment to simply be in compliance with the SEND Standard; and then went on to talk about how some organizations are utilizing the SEND Standard Beyond Compliance. Again, a topic that will be familiar to regular readers.
March has always been a busy month in the SEND calendar, and I realize that this posting seems to have been a combination of news updates, and call backs to my previous posts, like some bizarre greatest hits album. That’s the nature of the beast.
My next post will return to musings and opinions. How about: When a standard is supported but not required – what’s the point? Would anyone submit SEND when it’s supported but not required?
Till next time, from your friendly neighborhood SEND-Geek