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# FDA Accepts 1st Drug-Induced Liver Injury Tool
- URL: https://www.fdaweb.com/fda-accepts-1st-drug-induced-liver-injury-tool/
- Published: 2026-06-03T12:00:00.000Z
- Updated: 2026-09-14T13:40:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161250

FDA says CDER has accepted the first letter of intent for an *in silico* drug development tool (DDT) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) DDT qualification program. Accepting the letter of intent is the first of three steps the DDT must pass to be qualified for use by drug manufacturers.

An agency [statement](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver?ref=fdaweb.com) says the DDT is an artificial intelligence-driven digital liver model for predicting drug-induced liver injury (DILI). The statement says the DDT “aligns with FDA’s vision of optimizing drug development and evaluation while minimizing the use of animals in the nonclinical space, potentially expediting the availability of safe and effective treatments.”

The DDT will be used to assess DILI risk for small-molecule new drug candidates. If qualified, the test will complement existing data and support more informed decision-making before starting Phase 1 clinical trials, FDA says.

The company will submit a Qualification Plan for step two in the qualification process, and then will submit a full qualification package. Upon successful qualification, drug companies may use the qualified DDT in drug development programs within the specified context of use, the statement says.