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ICCVAM Biennial Report 2018-2019

Biennial Progress Report 2018-2019 Interagency Coordinating Committee on the Validation of Alternative Methods

Implementation of the FDA Predictive Toxicology Roadmap

In December 2017, FDA published its Predictive Toxicology Roadmap for integrating predictive toxicology methods into safety and risk assessments. The Predictive Toxicology Roadmap presents a framework for new or enhanced FDA engagement in the science of toxicology that includes six elements:

  1. An organizing committee to help identify areas where research is needed and reduce duplication of efforts.
  2. Training in use of new test methods.
  3. Communication among the agency, sponsors, and test method developers.
  4. Fostering collaborations across sectors and disciplines nationally and internationally.
  5. Research to identify data gaps and promote promising technologies.
  6. Oversight to track progress.

FDA held a public hearing on September 12, 2018, to solicit comments on the roadmap. A public workshop on September 18, 2019, highlighted work done by FDA to support and implement the roadmap.