Regulatory Submission Blog

Guest contributor, Christy Kubin from Charles River Laboratories, shares her thoughts on SEND Conformance Rules.

The SENDIG-GeneTox is nearing completion, focusing on in vivo Micronucleus and Comet assays, with public review expected early Q3 2022 and final release by Q1 2023.

SEND may not be everyone’s passion, but for those of us who love it, we’re here to ensure standards are met, so others don’t have to worry.

Key SEND milestones in 2022 include the long-awaited SENDIG-DART update for Juvenile Tox and the first SENDIG-GeneTox release—both aligning more closely with evolving FDA guidance.

As data exchange gains momentum in pharma, SEND could play a key role, but practical challenges like scope, effort, and value still need addressing.

SEND may feel fast or slow depending on your perspective, but for those driving its progress, the pace can feel glacial despite years of dedicated effort.