Science & Research

FDA's Predictive Toxicology Roadmap

FDA ToxiFDA's Predictive Toxicology Roadmap

FDA is holding a public hearing on Wednesday, September 12, 2018 from 9 a.m. to 4 p.m. to solicit comments on its Predictive Toxicology Roadmap.   The Agency is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate them into regulatory review, as applicable. 

Persons seeking to attend the public hearing must register by Wednesday, August 29, 2018. 

Adobe Connect access/webcast registration information:

Remote Access Instructions/Webcast Registration (pre-registration is required): To register for the Part 15 public hearing webcast, please click the on link below and then follow the instructions on the registration page. After you register you will receive a link via e-mail as an Outlook calendar invitation with information on how to access the live webinar. You must log in with your user name and password, which you create when you register. Individuals must pre-register at least one day before the event to ensure that the access link e-mails and Outlook invitations are received.

Register here for webcast or in-person (public attendees and FDA staff)
For technical assistance:  Please contact Jeffery Rexrode at

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.

Page Last Updated: 06/28/2018
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