Regulatory SubmissionSENDSensible SEND
Countdown to the next SEND Requirements
Marc Ellison
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.
Regulatory Submission Blog
Regulatory SubmissionSENDSensible SEND
SEND Conformance Rules are NOT Boring!
Marc Ellison
Guest contributor, Christy Kubin from Charles River Laboratories, shares her thoughts on SEND Conformance Rules.
Regulatory SubmissionSENDSensible SEND
Are we there yet – Where’s the GeneTox IG?!
Marc Ellison
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.
Regulatory SubmissionSENDSensible SEND
SEND: it’s not everyone’s cup of tea…
Marc Ellison
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.
Regulatory SubmissionSENDSensible SEND
SEND in 2022 – so what’s next?
Marc Ellison
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.
Regulatory SubmissionSENDSensible SEND
The standard for the altruistic exchange of nonclinical data
Marc Ellison
As data exchange gains momentum in pharma, SEND could play a key role, but practical challenges like scope, effort, and value still need addressing.
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