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Chemistry for Toxicological Risk Assessment—Transitions in Expected Approach

Published In: MDI Online

FDA’s expectations regarding ChemTox will be discussed during an upcoming MD&M West 2020 presentation.

One of the cornerstones of biocompatibility evaluations is the use of toxicological risk assessment to screen for potential hazards and safeguard against long-onset risks like cancer. While there is an abundance of toxicological literature available, and the techniques of toxicological risk assessment are generally accepted, the process for conducting the underlying chemistry studies is less mature. FDA has been building finesse in reviewing chemistry studies, helping the testing facilities to be more aware of the nuances in chemistry. New internal awareness and recent reports with poorly conducted studies used for regulatory submissions have raised anxiety regarding the extent of use of chemistry for toxicology (“ChemTox”) within the agency over the last year and motivated changes in expectations.


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Matthew Jorgensen

Matthew Jorgensen

Chemistry and Materials Scientist

Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. His analytical chemistry background includes research in organic chemistry synthesizing and analyzing a naturally occurring anti-cancer drug, computational treatment of photothermal spectroscopy, and professionally in a commercial lab. Most of his materials...