FDA Sets Public Hearing on Predictive Toxicology Roadmap

The agency's Toxicology Working Group recommended a six-part roadmap for achieving FDA's goals of ensuring the agency continues to use cutting-edge science to assess the safety and effectiveness of its regulated products and also leverages advances made in toxicology.

The U.S. Food & Drug Administration will hold a public hearing Sept. 12 to get public comments on its Predictive Toxicology Roadmap. At the hearing, scheduled to last from 9 a.m. to 4 p.m., 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. Anyone interested in attending the hearing must register by Aug. 29.

Released in December 2017, the roadmap is a 16-page document developed by FDA's Toxicology Working Group at the request of FDA's commissioner. The working group recommended a six-part roadmap for achieving FDA's goals of ensuring the agency continues to use cutting-edge science to assess the safety and effectiveness of its regulated products and also leverages advances made in toxicology.

The six parts are:

  • Organizing committee -- the Toxicology Working Group.
  • Training -- Saying continuing education in new predictive methods is essential for FDA regulators, the working group has established an agency-wide education calendar of events and a toxicology seminar series to provide this.
  • Continued communication with stakeholders.
  • Collaborations across sectors and disciplines both nationally and internationally.
  • Research to identify gaps and support intramural and extramural research to ensure the most promising technologies are identified, developed, validated, and integrated into the product pipeline.
  • Oversight -- The working group will track progress on these recommendations and report to FDA's chief scientist annually.

In its online page inviting public participation, FDA said it expects "breakthrough methods" will help it move products to market faster and prevent products with increased toxicological risk from reaching the market, and these new technologies are reducing the need for animal testing – furthering FDA's goal of refining, reducing, and replacing testing on animals.

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