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

• Date: November 03, 2009
• Source: www.fda.gov

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

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