On December 6, 2017, the U.S. Food and Drug Administration (FDA) informed that its Toxicology Working Group has prepared a predictive toxicology roadmap, outlining “a six-part framework for integrating predictive toxicology methods into safety and risk assessments.” The roadmap calls for “research to identify data gaps and to support intramural and extramural research to ensure that the most promising technologies are developed, validated, and integrated into the product pipeline.” Predictive toxicology methods, such as organs on a chip or mathematical modeling, may improve FDA’s “ability to quickly and more accurately predict potential toxicities and reduce associated risks,” the agency stated. Also, such methods can help reduce the need for animal testing. FDA announced that it will be holding a public workshop “for sharing ideas, discussing new technologies, and highlighting collaborations that are developing and testing new methods.”

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Denise M. Hinton and Suzanne Fitzpatrick (December 6, 2017). “FDA launches predictive toxicology roadmap to enable advances in toxicity testing.FDA


FDA (December 2017). “FDA’s predictive toxicology roadmap.(pdf)