FDA Reviews AI Tool to Predict Drug Related Liver Damage
The FDA accepted a letter of intent for an AI-driven digital liver model under its ISTAND pilot program. This tool aims to improve early safety assessments and reduce animal testing by predicting toxicity risks in new small-molecule drugs before human trials begin.
The United States Food and Drug Administration (FDA) accepted a letter of intent on Wednesday for an AI-based tool designed to predict drug-induced liver injury. This digital liver model is the first AI-driven safety tool admitted to the agency’s Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program. The move addresses a primary cause of clinical trial failures by improving early safety assessments before human testing begins.
