federal_register: E9-18135

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
E9-18135 Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Availability Notice 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. 2009-07-30 2009 7 https://www.federalregister.gov/documents/2009/07/30/E9-18135/guidance-for-industry-on-drug-induced-liver-injury-premarketing-clinical-evaluation-availability https://www.govinfo.gov/content/pkg/FR-2009-07-30/pdf/E9-18135.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...  

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