September 18, 2019 Public Workshop
Implementing FDA's Predictive Toxicology Roadmap:
An Update of FDA's Activities
On Wednesday, September 18, 2019, FDA hosted the public workshop Implementing FDA's Predictive Toxicology Roadmap: An Update of FDA's Activities to highlight the work FDA has been doing to support and implement FDA’s Predictive Toxicology Roadmap. The agenda and complete webcast sessions are available below.
September 12, 2018 Public Hearing
FDA's Predictive Toxicology Roadmap
FDA previously held a public hearing on Wednesday, September 12, 2018 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 and the presenters' slides are available below.
Agenda (PDF, 110 KB)
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 Products, Dr. Kimberly Ehman, Altria Client Service, Inc.
Imperial Tobacco Limited, Dr. Gary Phillips
Advancing the Toxicology Toolbox Using Predictive Human In Vitro 3D Models, Jan Lichtenberg, CEO, In Sphero
Novel Genomic, Cell and Biomarker-based Approaches for Accelerating Drug Development, Bob Young, MilliporeSigma
FDA Predictive Toxicology Roadmap Comments, Dr. Kevin Cross, Leadscope
Physicians Committee Input at FDA Predictive Toxicology Roadmap Stakeholder Meeting, 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.