FDA’s Nonclinical Testing Rule: What It Means for CROs Offering NAMs
US FDA's direct final rule rewrites drug and biologics regulations to cover in vitro, in silico, and organ-chip studies, giving NAM-ready CROs a clearer opening with sponsors
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Toxicology & Biocompatibility Testing assesses the potential harmful effects of chemical, physical, or biological agents on living organisms, and the interaction between medical devices/materials and biological tissues, respectively.
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US FDA's direct final rule rewrites drug and biologics regulations to cover in vitro, in silico, and organ-chip studies, giving NAM-ready CROs a clearer opening with sponsors
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