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Entreprise · 25/10/20071 min de lecture
Draft Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Availability
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Résumé
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Drug-Induced Liver Injury: Premarketing Clinical Evaluation."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). This guidance defines severe DILI as injury that is fatal or requires liver transplantation. This guidance does not address the postmarketing evaluation of DILI.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →