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  1. About Science & Research at FDA

FDA's Predictive Toxicology Roadmap

FDA's Predictive Toxicology Roadmap

FDA's Predictive Toxicology Roadmap



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.



Morning Session

  8:30 a.m. to 10:10 a.m.
10:30 a.m. to 12:00 p.m.  

Afternoon Session

1:00 p.m. to 2:20 p.m.  
2:40 p.m. to 4:00 p.m.  

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.

FR Notice on Registration for Public Meeting on Predictive Toxicology Roadmap

Webcast of Sept. 12, 2018  Public Hearing 

Agenda (PDF, 110 KB)


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

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.

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