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ATLANTA — The U.S. FDA's Center for Drug Evaluation and Research said on Wednesday it has accepted a letter of intent for an artificial intelligence-based drug development tool designed to help predict drug-induced liver injury.
Drug-induced liver damage is a major cause of trial failures, and current methods do not reliably predict human risk. The U.S. Food and Drug Administration said the tool could potentially help improve early safety assessments, reduce reliance on animal testing and support more informed decisions before human trials begin.
The tool, an AI-driven digital liver model, has been admitted to the agency's Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot programme.
The model is designed to assess the risk of liver toxicity in new small-molecule drugs by comparing their chemical structures with existing medicines that have known safety profiles.
"New technologies are showing incredible promise in helping improve and streamline drug development, with the ultimate goal of enhancing patient care," said Michael Davis, CDER's acting director.
The acceptance marks the first step in a multi-stage qualification process that would allow drugmakers to use the tool in regulatory submissions if approved.
The Drug Development Tool qualification program works with developers to guide tools for a specific use, and a letter of intent is the first submission stage used by the FDA to determine whether a tool will be accepted into the program.
