Regulatory Submission Blog

FDA SEND feedback letters often cause panic, but 95% of the time, no action is required. They’re meant to guide future improvements and help raise industry standards.

March marks the countdown to new FDA SEND requirements, including SEND 3.1.1, SENDIG-DART 1.1, and Define-XML 2.1—organizations have 12 months to prepare.

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.