Science & Research

FDA's Predictive Toxicology Roadmap

FDA ToxiFDA's Predictive Toxicology Roadmap

FDA held a public hearing on Wednesday, September 12, 2018 from 9 a.m. to 12 p.m. at FDA Headquarters to solicit comments on its Predictive Toxicology Roadmap.   The Agency sought comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate them into regulatory review, as applicable.  The webcast for the meeting is available below and the presenters' slides will be available on this web page shortly.

Webcast of Sept. 12 Public Hearing  

Links to the slides from the public hearing are being made available below as they are received:

Applying a Threshold of Toxicological Concern in Risk Assessments to Address the Complex Chemical Mixtures of Tobacco Productsdisclaimer icon, Dr. Kimberly Ehman, Altria Client Service, Inc.

Imperial Tobacco Limiteddisclaimer icon, Dr. Gary Phillips

Advancing the Toxicology Toolbox Using Predictive Human In Vitro 3D Modelsdisclaimer icon, Jan Lichtenberg, CEO, In Sphero

Novel Genomic, Cell and Biomarker-based Approaches for Accelerating Drug Developmentdisclaimer icon, Bob Young, MilliporeSigma

FDA Predictive Toxicology Roadmap Commentsdisclaimer icon, Dr. Kevin Cross, Leadscope

Physicians Committee Input at FDA Predictive Toxicology Roadmap Stakeholder Meetingdisclaimer icon, Elizabeth Baker, Esq., Physicians Committee for Responsible Medicine

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.

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.

Page Last Updated: 01/30/2019
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