FDA Launches Predictive Toxicology Roadmap to Enable Advances in Toxicity Testing

By: RADM Denise M. Hinton and Suzanne Fitzpatrick, Ph.D.

Toxicology testing plays a pivotal role in ensuring the safety of FDA-regulated products. During the development and evaluation of almost all FDA-regulated products, testing is performed on people or animals to identify any potential risk from chemical, physical, or biological agents.

RADM Denise Hinton

RADM Denise M. Hinton, is FDA’s Acting Chief Scientist

Today, novel methods such as organs on a chip or mathematical modeling are being developed for toxicity testing that are generating unique opportunities to improve our ability to quickly and more accurately predict potential toxicities and reduce associated risks.

We expect these advances will help us move products to market faster while preventing products with increased toxicological risk from ever reaching the market. Moreover, in many cases, these technologies are reducing the need for animal testing – advancing FDA’s long sought goal of refining, reducing, and replacing testing on animals.

For a new testing method to be accepted for use in determining the safety of an FDA-regulated product, there must be sufficient convincing data to ensure that the method can be relied upon for both product development and regulatory decision-making. FDA evaluates the test or series of tests for their applicability, limitations, relevance, reliability, reproducibility, and sensitivity. Undergoing this process requires continuous dialogue and feedback among all our relevant stakeholders, beginning with developers and ending with qualification and acceptance by regulatory authorities.

A High-Priority for FDA

In 2016, FDA’s Commissioner tasked the agency’s Toxicology Working Group with developing a more efficient process for identifying and qualifying emerging predictive toxicology technologies. Established in 2015 and comprising senior FDA toxicologists across the agency, the Working Group has deep expertise in the various FDA product areas and knowledge of the differing legal authorities for evaluating safety and toxicity in those product areas.

FDA's Toxicology Roadmap

FDA’s Predictive Toxicology Roadmap, a six-part framework for integrating predictive toxicology methods into safety and risk assessments.

This week the Working Group laid out FDA’s 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. The roadmap also identifies toxicology issues that need addressing for FDA-regulated products and toxicology areas that could benefit from improved predictivity.

Suzanne Fitzpatrick

Suzanne Fitzpatrick, Ph.D., is the Senior Advisor for Toxicology in FDA’s Center for Food Safety and Applied Nutrition

FDA will be holding a public workshop as part of our efforts to foster opportunities for sharing ideas, discussing new technologies, and highlighting collaborations that are developing and testing new methods.

And, we want to encourage stakeholders to work with FDA as we leverage the collaborative expertise of our toxicologists across the agency to develop performance standards for emerging toxicity testing methods.

Because this is a high priority for the agency, FDA’s Toxicology Working Group will be reporting yearly to FDA’s Chief Scientist on progress made in this important effort. We’re confident that the successful implementation of FDA’s predictive toxicology roadmap and the continuing engagement of our diverse stakeholders will enable FDA to fulfill its regulatory mission today while preparing for the challenges of tomorrow.

RADM Denise M. Hinton, is FDA’s Acting Chief Scientist

Suzanne Fitzpatrick, Ph.D., is the Senior Advisor for Toxicology in FDA’s Center for Food Safety and Applied Nutrition

For more information please read:

Organs-on-Chips’ Technology: FDA Testing Groundbreaking Science

FDA Collaborates on Human on a Chip

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