Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Drug-Induced Liver Injury: Premarketing Clinical Evaluation." This guidance is intended to assist the pharmaceutical industry and others engaged in new drug development in the assessment of the potential of a drug to cause severe drug-induced liver injury (DILI) during the conduct of premarketing trials. This guidance defines severe DILI as injury that is fatal or requires liver transplantation.