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What Medical Device Manufacturers Need to Know about FDA’s Predictive Toxicology Roadmap

Published In: MD+DI

Toxicologists offer their perspectives on the future of testing. FDA recently published its Predictive Toxicology Roadmap to enable the adoption of advances in toxicity testing. While this announcement from FDA may not have any immediate effects on the toxicology testing for medical device manufacturers (MDMs), it anticipates the future evolution of toxicology testing. With the unprecedented advancements in technologies, globalization, and ever-changing challenges, FDA and other stakeholders must have a unified, comprehensive strategy. FDA’s Toxicology Working Group recommended a six-part roadmap to achieve the goal of upgrading toxicology tools and their regulatory acceptance for medical devices, pharmaceuticals, and food.

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Sarah Campbell

Sarah Campbell

PhD, DABT
Toxicology Expert

Dr. Campbell is a Board Certified Diplomate of the American Board of Toxicology. She has over 17 years of experience working in pharmacological and toxicological research as well as 19 years of applied analytical chemistry experience. Her particular areas of interest include medical device and pharmaceutical nonclinical program design and implementation, investigative toxicology, risk assessment...