Per the U.S. Food and Drug Administration, the FDA’s Center for Drug Evaluation and Research (CDER) has accepted the primary Letter of Intent (LOI) for an in silico drug growth software (DDT) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) DDT Qualification Program, the company introduced on 2026-06-03. The software, described by FDA as an AI-Driven Digital Liver Model, goals to assist predict drug-induced liver damage (DILI) for small-molecule candidates by evaluating chemical buildings in opposition to historic reference medicine with identified DILI danger, and is classed as a New Approach Methodology (NAM). “New technologies are showing incredible promise in helping improve and streamline drug development,” mentioned Michael Davis, MD, PhD, Acting Director of CDER. The FDA describes the LOI acceptance as step one in a three-step DDT qualification course of.