Science & Research

FDA's Predictive Toxicology Roadmap

FDA ToxiFDA's Predictive Toxicology Roadmap

Toxicology testing plays a critical role in ensuring the safety of FDA-regulated products.  Breakthrough methods like organs on a chip or mathematical modeling are being developed for toxicity testing that are generating unique opportunities to improve FDA’s ability to quickly and more accurately predict potential toxicities and reduce associated risks.

FDA expects these advances will help us move products to market faster and prevent products with increased toxicological risk from reaching the market. In many cases, these technologies are, in fact, reducing the need for animal testing – furthering FDA’s long sought goal of refining, reducing, and replacing testing on animals.

In December 2017, FDA unveiled its Predictive Toxicology Roadmap, a six-part framework for integrating predictive toxicology methods into safety and risk assessments.  Among other recommendations, it calls for FDA 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.

FDA will be holding a public workshop as part of our efforts to encourage stakeholders to share ideas, discuss new technologies, and highlight collaborations that are developing and testing new methods.  We will be providing more information on this workshop shortly and look forward to the continuing engagement of our diverse stakeholders.


Page Last Updated: 04/16/2018
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