Comment from Nicole Mark
AnonymousSupportIndividual
Summary: The commenter supports the FDA's efforts to expand regulatory pathways for scientifically validated alternatives to animal testing, such as human cell-based testing and organ-on-chip technology. They argue that these New Approach Methodologies (NAMs) can improve translational relevance in drug development while reducing reliance on animal studies.
I support the FDA continuing to expand clear regulatory pathways for scientifically validated alternatives to animal testing during drug development. Human-relevant methods such as human cell-based testing, organ-on-chip technology, and computational models have the potential to improve translational relevance while reducing reliance on animal studies when scientifically appropriate. I encourage the FDA to continue modernizing its approach and supporting the responsible evaluation and acceptance of validated New Approach Methodologies (NAMs). I support the FDA continuing to expand clear regulatory pathways for scientifically validated alternatives to animal testing during drug development. Human-relevant methods such as human cell-based testing, organ-on-chip technology, and computational models have the potential to improve translational relevance while reducing reliance on animal studies when scientifically appropriate. I encourage the FDA to continue modernizing its approach and supporting the responsible evaluation and acceptance of validated New Approach Methodologies (NAMs).