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  1. About Science & Research at FDA

FDA's Predictive Toxicology Roadmap

FDA's Predictive Toxicology Roadmap


FDA's Predictive Toxicology Roadmap


FDA’s Predictive Toxicology Roadmap was published in December 2017 by the Food and Drug Administration’s (FDA’s) Toxicology Working Group. It describes FDA’s current thought on viable ways to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate them into FDA regulatory review.

This six-part framework outlines Agency priorities and engagement in predictive toxicology, emphasizes the importance of the context of use, and identifies toxicology issues related to FDA-regulated products. FDA’s Predictive Toxicology Roadmap also identifies the toxicology areas that could benefit from improved predictivity as well as promising new technologies that could potentially meet these needs and support animal 3Rs (Replacement, Reduction, and Refinement).

Advancing Alternative Methods at FDA

As part of efforts to support its Toxicology Working Group in advancing the goals of FDA's Predictive Toxicology Roadmap, the agency formed the Alternative Methods Working Group in 2020.  A dedicated web section Advancing Alternative Methods at FDA serves as a platform for the latest FDA activities in this area.  Among them are a webinar series inviting developers to showcase their cutting-edge technologies to FDA scientists and publications on alternative methods co-authored by FDA scientists. 


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