Regulatory Submission Blog

AI has clear uses in fraud detection, cybersecurity, and supply chain management, and seems to be used in innovative applications across various industries but does it have an application for SEND?

Due to be published in 2026, SEND 4.0 is the next update due for the SEND standard.

In this ever-evolving ecosystem, the key to unlocking a future rich in insights and possibilities is to harness the power of the data cycle.

Aside from implementation of the Genetox IG, the other main activity that is currently advancing is SEND v4.0.

People are now more focused on the uses of SEND beyond submission, as well as seeing the scope of SEND widening further as we close out the year.

The FDA have been describing some of the issues that they are seeing with the SEND packages for safety pharmacology studies.