Business · 25/10/2007Updated: 10/17/2026 · 1 min read

FDA Releases Draft Guidance on Drug-Induced Liver Injury for Premarketing Clinical Evaluation

The Food and Drug Administration (FDA) has made available a draft guidance document to help the pharmaceutical industry assess the risk of severe drug-induced liver injury (DILI) in new drug development, defining DILI as fatal or requiring liver transplantation.