- Meeting Agenda
- Guidance for Industry (Draft): Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 355KB) (posted 25 October 2007)
- Comments received by 24 December 2007 for Docket No. 2007D-0396
- Federal Register Notice of Reopening of Comment Period (PDF - 54KB) (announced March 6, 2008)
Public conference was held on March 26 and 27, 2008. Additional written comments about the draft guidance or the conference will be accepted up to 30 June, 2008 for Docket No. FDA-2008-D-0128.
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