by Marc Ellison | Aug 4, 2025 | Regulatory Submission, SEND, Sensible SEND
In my previous blog post we discussed the feedback the FDA received regarding the new CDISC standard Dataset-JSON v1.1 when they issued their Federal Register Notice. One of the standout points was the difference of opinion concerning the readiness of tools. So, in...
by Marc Ellison | Jul 4, 2025 | Regulatory Submission, SEND, Sensible SEND
You may recall that recently the FDA asked for feedback on potential adoption of the new CDISC standard: Dataset-JSON v1.1 as a replacement for XPT files. Well, the feedback was public and I read through all the comments and I’ll summarize here, so you don’t need to...
by Marc Ellison | Jun 12, 2025 | Regulatory Submission, SEND, Sensible SEND
I met up with a fellow CDISC volunteer at the Society of Toxicology meeting recently, and during the general chit-chat, he mentioned that he had reviewed SEND v4.0 but wasn’t really considering its impact yet. Me, on the other hand, I told him it was already...
by Marc Ellison | May 29, 2025 | Regulatory Submission, SEND
The Standard for the Exchange of Nonclinical Data (SEND) is essential for organizations submitting nonclinical study data to the FDA. Although standardization and implementation guides are helpful, it can still be unclear when SEND applies. Implementing SEND can be...
by Marc Ellison | May 16, 2025 | Regulatory Submission, SEND, Sensible SEND
Ever since I started working on SEND, there was frustration with the requirement to use SAS transport file as the file format. Over the years CDISC, PHUSE and FDA all tried to push forward with alternatives. Does anyone remember experimenting with Dataset -XML? Last...
