How will the FDA’s new Toxicology Roadmap affect animals?

Scientists have been developing new tools and methodologies to better predict product safety and move the field of toxicology forward. And importantly, the U.S. Food and Drug Administration (FDA) has acknowledged that advances in animal alternatives such as stem cell research, organs-on-chips and math models are “creating unique opportunities to improve toxicology’s predictive ability, potentially enhancing our ability to predict risk.” The increased use of these alternative models should lead to the replacement and reduction of animal testing in this area.

The FDA also acknowledges, however, that more needs to be done to ensure that these predictive toxicology methods are better identified and integrated into safety and risk assessments. Therefore, last year, the FDA Commissioner asked the Toxicology Working Group, which is comprised of senior toxicologists from the FDA’s product centers and its National Center for Toxicological Research, to develop a comprehensive strategy to strengthen the agency’s commitment to develop and use more predictive technologies for safety testing of FDA-regulated products.

Earlier this month, the Working Group reported on its strategy to streamline the process of developing and evaluating novel predictive toxicology methods for safety and risk assessments. They recommended a six-part Predictive Toxicology Roadmap for new or enhanced FDA engagement in the science of toxicology. This Roadmap includes the establishment of an organizing committee, along with training, continued communication, collaborations, research and oversight. 

The Toxicology Working Group will be tracking the progress of these recommendations and reporting to the FDA Chief Scientist on an annual basis.

According to the FDA’s Acting Chief Scientist Denise Hinton, and Suzanne Fitzpatrick, Senior Advisor for Toxicology in FDA’s Center for Food Safety and Applied Nutrition, using emerging technologies for toxicity testing “will help us move products to market faster while preventing products with increased toxicological risk from ever reaching the market.”  They also reiterated that “these technologies are reducing the need for animal testing—advancing FDA’s long-sought goal of refining, reducing, and replacing testing on animals.”

We will be sure to keep you updated on the progress that comes from this exciting initiative, and will report back on the impact that this Predictive Toxicology Roadmap has on the use of animals in this area of testing.


“FDA’s Predictive Toxicology Roadmap.”  U.S. Food and Drug Administration, December 2017.

“FDA Launches Predictive Toxicology Roadmap to Enable Advances in Toxicity Testing.” FDA Blog, December 6, 2017.

This entry was posted in News and tagged on December 18, 2017.
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