Predictive toxicology for regulatory decisions: Implementing new approaches at the US Food and Drug Administration

抄録

Toxicology is critical to US Food and Drug Administration’s (FDA) mission because it is applied across the breadth of FDA-regulated product areas.  Toxicological testing is done during the development and evaluation of FDA-regulated products, from human and animal drugs and medical devices to food and food ingredients, human biologics, and tobacco products.  Today’s advances in systems biology, stem cells, engineered tissues, and mathematical modeling are offering exciting opportunities to improve toxicology’s predictive ability, potentially enhancing FDA’s ability to quickly and more accurately predict potential toxicities--and reduce associated risks to the public.  These breakthroughs also hold the potential for replacing, reducing, and/or refining animal testing. FDA’s Predictive Toxicology Roadmap is a six-part framework for integrating novel predictive toxicology methods into safety and risk assessments of its products. Critical to the implementation of the roadmap is partnership with FDA’s stakeholders, including NIH, EPA and other federal agencies through programs such as Toxicology Testing in the 21st Century (Tox21) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).  FDA’s unprecedented role in the development and evaluation of the organs-on-a-chip technology with sister federal agencies and industry will be described and offered as an example of how FDA is enabling innovation in this exciting field.