by Marc Ellison | Nov 22, 2023 | Regulatory Submission, SEND, Sensible SEND
This past week, the FDA gave a webcast describing some of the issues that they are seeing with the SEND packages for safety pharmacology studies. The agency informed the industry that they are currently receiving around 200 such studies per year and were facing...
by Marc Ellison | Oct 24, 2023 | Regulatory Submission, SEND, Sensible SEND
Last week was the FDA Public Meeting at the CDISC SEND F2F conference and the agency gave clarification about the requirement for juvenile tox studies, and I feel I need to comment. The agency has always been very clear that such studies which include certain...
by Marc Ellison | Sep 27, 2023 | Regulatory Submission, SEND, Sensible SEND
This is a question that has continually arisen since organizations first started adopting SEND. If we just add all the SEND Controlled Terminology (CT) to our preclinical lexicons, then surely it makes SEND dataset generation automatic? It seems obvious, right? Well...
by Marc Ellison | Aug 30, 2023 | Regulatory Submission, SEND, Sensible SEND
For this blog post, I’ve asked our VP Translational Science, Dr Brenda Finney, to share her thoughts on the use of SEND for data exchange in data warehouses like our Centrus platform which is built on the ToxHub database, which was previously created by the eTransafe...
by Marc Ellison | Aug 3, 2023 | Regulatory Submission, SEND, Sensible SEND
Have I been repeating myself? I’ve been blogging about SEND since October 2020 and this is my 70th post, so yes, it’s unsurprising that I’ve repeated one or two ideas along the way. There are main topics that keep reoccurring. Subjects that need revisiting partly with...
