What’s the deal with the FDA Feedback Letters?

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 …

SEND Conformance Rules are NOT Boring!

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 …

Are we there yet – Where’s the GeneTox IG?!

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.  …

SEND: it’s not everyone’s cup of tea…

I make no secret of how much I love working with the SEND standard. I really enjoy both the time I donate to CDISC to help develop the standard; and the time I spend helping develop solutions that allow organizations to create and consume SEND datasets. This year marks my 10-year anniversary of working with …

The standard for the altruistic exchange of nonclinical data

This will be my final blog post of 2021, as I’ll be taking a break over the festive season. The season of goodwill is very apt for what’s on my mind this week. Whether it’s media reports of how COVID-19 vaccines were collaboratively developed so rapidly; or the rise of consortia for exchanging pharmaceutical data …

The relative speed of SEND development

As we approach the holiday season and the eventual end of another year, I’m again thinking of how fast this year has passed. Also remembering childhood times when Christmas seemed to take forever to arrive. Now it seems I barely catch my breath and another year flies by. So yes, time is most definitely relative. …

FDA provides more detail on the Scope of SEND

This past week was the CDISC SEND Virtual Face-to-Face meeting, and yes, I still snicker like a schoolboy at calling something a ‘virtual face-to-face’, but hopefully it’s the last one and by next Spring we can be face-to-face in person. Anyways, as is usual, the highlight of the week was the FDA public meeting. As …