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Negocios · 30/7/20091 min de lectura
Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Availability
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Resumen
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.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →