Business · 30/07/2009Updated: 10/17/2026 · 1 min read
FDA Releases Guidance on Drug-Induced Liver Injury for Pharmaceutical Industry
Summary
The Food and Drug Administration (FDA) has made available a new guidance document to help the pharmaceutical industry assess the risk of severe drug-induced liver injury (DILI) during premarketing clinical trials, which is defined as fatal or requiring liver transplantation.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →