US FDA to review AI-based tool to predict drug-related liver damage

The FDA has accepted an AI-driven “digital liver” tool into its ISTAND pilot program to help predict drug-induced liver injury.
The model compares new small-molecule drugs to existing medicines to flag liver-toxicity risk, aiming to catch safety problems earlier.
Acceptance is the first step in a qualification process that could let drugmakers use the tool in regulatory submissions and potentially reduce animal testing.