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Upcoming Public Workshop to Provide Update on FDA’s Predictive Toxicology Roadmap

Adequate toxicological data – often involving the sacrifice of laboratory animals – are necessary for reaching a safety decision on the products that are subject to FDA’s regulatory review.  FDA’s Predictive Toxicology Roadmap, published in December 2017, is a six-part framework for integrating predictive toxicology methods into the Agency’s safety and risk assessments.  FDA’s initial public workshop on the Roadmap, held September 12, 2018, covered human tissue on a computer chip and other  new technologies already used in industry that support animal 3Rs (Replacement, Reduction, and Refinement).  FDA also highlighted new and revised guidance documents that have incorporated some of the new toxicology approaches.

On Wednesday, September 18, 2019, FDA will host another public workshop, Implementing FDA’s Predictive Toxicology Roadmap: An Update of FDA’s Activities, to highlight recent work.  While much of the new technology is being developed with a focus on drug screening and toxicity testing, a number of predictive modeling approaches may also be applicable to other FDA-regulated industries such as food and tobacco products.  For example, the agenda for the 2019 Roadmap workshop features experts from FDA’s Center for Food Safety and Applied Nutrition (CFSAN) speaking on topics including Tox21, EU ToxRisk, and FDA’s application of an expanded decision tree and the threshold of toxicological concern (TTC) approach for safety assessment.

Interested parties may attend the Roadmap workshop in person or via Adobe Connect.  Attendees must register by Monday, September 16, 2019.

© 2019 Keller and Heckman LLP


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...