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.