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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
Principal Toxicologist

Dr. Campbell is a Board Certified Diplomate of the American Board of Toxicology. She has over 20 years of experience working in toxicological research, 20 years of applied analytical chemistry experience, 14 years of experience in pharmaceutical research (including both clinical and nonclinical), and 12 years of experience as a bench chemist. Her particular areas...