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.

Location

Food and Drug Administration
White Oak Campus Bldg. 31, Great Room (Room 1503A)
10903 New Hampshire Ave.
Silver Spring, MD 20993
United States

FR Notice on Registration for Public Meeting on Predictive Toxicology Roadmap

Webcast of Sept. 12, 2018  Public Hearing 

Agenda (PDF, 110 KB)

Slides

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.

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