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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