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, as applicable.
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).
- Public Workshop
September 18, 2019: Implementing FDA's Predictive Toxicology Roadmap: An Update of FDA's Activities
- Public Hearing
September 12, 2018: FDA's Predictive Toxicology Roadmap