Regulatory Submission Blog

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.

What is the big deal with requiring juvenile studies in SEND v3.1/3.1.1?

There are advantages to aligning our nonclinical lexicons with the SEND CT terms, but there are potential pitfalls and things to consider too.