The FDA Toxicology Working Group has laid out FDA’s Predictive Toxicology Roadmap, a six-part framework for integrating predictive toxicology methods into safety and risk assessments. Among other recommendations, it calls for FDA research to identify data gaps and to support intramural and extramural research to ensure that the most promising technologies are developed, validated, and integrated into the product pipeline. The roadmap also identifies toxicology issues that need addressing for FDA-regulated products and toxicology areas that could benefit from improved productivity. The six-part framework includes steps to increase communication with the various FDA centers on emerging predictive toxicology methods, training and educating FDA staffers, encouraging sponsors to submit scientifically-valid approaches early in the regulatory process, assessing data gaps and supporting intramural and extramural research to identify the most promising technologies, and further efforts to ensure the new technologies are developed, validated and integrated into pipelines.
The roadmap notes that some of the areas that could benefit the most from improvements include identifying rare or idiosyncratic toxicities, characterizing potential non-genotoxic carcinogens and understanding chemical transport into sensitive biological compartments (e.g., brain or fetus) and understanding how Adverse Outcome Pathways (AOPs) can reduce uncertainty in identifying hazards and assessing risks.
The full report is available HERE.