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# Positive CDER Response to Liver Safety Biomarker
- URL: https://www.fdaweb.com/positive-cder-response-to-liver-safety-biomarker/
- Published: 2020-07-22T12:00:00.000Z
- Updated: 2026-09-14T16:22:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147253

The CDER Biomarker Qualification Program has responded positively to a C-Path Predictive Safety Testing Consortium/Duchenne Regulatory Science Consortium qualification plan for glutamate dehydrogenase (GLDH) as a safety biomarker for drug-induced liver injury. A C-Path [statement](https://www.eurekalert.org/pub%5Freleases/2020-07/cpi-cpd072120.php?ref=fdaweb.com) says the two consortia “provided scientific evidence supporting the use of GLDH as an important and accurate measurement of drug-induced liver injury in clinical trials involving patients affected by inherited muscle disorders, such as Duchenne muscular dystrophy or idiopathic inflammatory myopathies, and muscle damage caused by strenuous exercise or drug-induced muscle injury.”