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FDA Unveils Six-Part Toxicology Roadmap to Expand Predictive Capabilities

Posted 06 December 2017 | By Zachary Brennan 

FDA Unveils Six-Part Toxicology Roadmap to Expand Predictive Capabilities

The US Food and Drug Administration’s (FDA) Toxicology Working Group this week laid out a six-part roadmap to help the agency better evaluate new methodologies and technologies for their potential to expand FDA’s toxicology predictive capabilities and to potentially reduce the use of animal testing.

"Acceptance of any new toxicology methods will require sufficient convincing data as well as continuous dialogue and feedback among all relevant stakeholders from development to implementation, including qualification and acceptance by regulatory authorities," Denise Hinton, FDA’s acting chief scientist, wrote in a blog post published Wednesday.

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.

FDA’s Center for Drug Evaluation and Research is also working with the International Conference on Harmonisation (ICH) to consider the regulatory use of alternative test methods for reproductive toxicity testing, as outlined in the Step 2 of ICH’s S5(R3), the agency said.

FDA’s Predictive Toxicology Roadmap 

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