Alternative Models Use: Regulatory Context
Donna Mendrick, Associate Director of Regulatory Activities, US Food and Drug Administration (FDA)
In 2017 FDA published the Predictive Toxicology Roadmap
(https://www.fda.gov/science-research/about-science-research-fda/fdas-predictive-toxicology-roadmap)-a
framework for integrating predictive toxicology methods into safety and
risk assessments. FDA welcomes data from alternative methods and is
working internally and externally to learn more about technologies such
as MPS. This presentation will provide an overview of MPS work being
done within FDA and the actions being taken to help move alternative
assays into a regulatory context.
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