RAPS Reports FDA Unveils Six-Part Toxicology Roadmap to Expand Predictive Capabilities

Regulatory Focus, Zachary Brennan, December 6, 2017: “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… 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.” Here’s the full story and here’s a link to contact us for help with your toxicology waiver.