I think that the first expansion will be into tissue cross-reactivity tests, which can be critical to establish MABEL. I know that some sites were already being audited, but perhaps there were facilities only performing tissue cross-reactivity that challenged the mandate to audit.
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Joleen White Ph.D.
AAPS 2024 Global Health Community Chair
Bioanalytical 101 Course Development
Senior Advisor
BioData Solutions LLC
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 06-02-2025 08:44
From: Mark Arnold
Subject: FDA Updates Bioresearch Monitoring Program to include GLP in vitro tests
Last week the FDA updated its Compliance monitoring program Chapter 48 – Bioresearch Monitoring to include 'in vitro' GLP tests (see p25 in the linked document). Whether this is related to the Agency's plans for implementing Novel Alternative Methodologies to replace animal safety testing in coming years remains to be seen.
#fda #NAM #GLP #InVitro
https://www.fda.gov/media/75891/download
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]
Bioanalytical Solution Integration
LinkedIn: https://www.linkedin.com/in/markearnoldphd/
Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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