I started Sensible SEND thinking back to 2012 and my initial impressions & experiences of SEND. You can read that early post here, but as a fish-out-of-water I really struggled and was completely disoriented by this new world I’d landed in. I remember thinking to myself “These people speak a different language! What’s a Tee-Pee …
Continue reading “Thinking about the challenges facing today’s SEND newbie”
For this week’s blog post, I thought it would be good to discuss the current use of the define.xml file within the nonclinical industry, so I’ve asked Charuta Bapat to discuss this with us as her enthusiasm for the Define-XML is bordering on infectious. Charuta works alongside me and is responsible for our define tools …
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 …
Continue reading “So, what did we learn from the FDA’s DART Fit For Use Pilot?”
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 …
This is the week of the CDISC Spring SEND Virtual Face-to-Face meeting, and yes that’s still an oxymoron, but hopefully this will be the final time as future Face-to-Face meetings are planned to back in person again. While tee week mainly focuses CDISC volunteers on progressing the standard, one of the highlights of the event …
Continue reading “A week of working on 3 separate Implementation Guides”
For a variety of different reasons, at several times this last week, I’ve reiterated my motivations for being a CDISC volunteer. I’ve discussed how I first fell into volunteering almost accidentally, not knowing what I was getting into, and discovering I had a real passion for SEND. I’ve also been talking about the importance of …
This week I caught up with my colleague and fellow SEND obsessive, Mike Wasko. I asked him for his opinions on the FDA feedback letters that sponsors receive after IND submissions. Specifically, his thoughts on their importance and impact – Here’s what he had to say: Whenever a sponsor receives a letter or feedback from …
Continue reading “What’s the deal with the FDA Feedback Letters?”
So here we are again in March, probably the most significant month in the SEND calendar. At Instem we are busy gearing up for the Society of Toxicology meeting, which will finally be in person again after a two-year hiatus, what with you-know-what. March also means that we are due to have the latest FDA’s …
Hey everyone – I’ve asked Christy Kubin over at Charles River Laboratories to share some of her thoughts here on Sensible SEND. As well as being a long term CDISC volunteer and co-author of the SEND IG, Christy now leads the SEND Conformance Rules Team and like me, she is a bit of a SEND …
This week I caught up with my colleague and fellow SEND obsessive, Mike Wasko who leads the CDISC team developing the SEND standard for Genetic Toxicology. I asked him “What is the current scope and timeline of the SEND Genetox Implementation Guide?”, and here’s what he had to say: “Some context is in order first. …
Continue reading “Are we there yet – Where’s the GeneTox IG?!”
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