Liver injury draft guidance update

FDA re-opens the comment period for the draft guidance "Drug-Induced Liver Injury: Premarketing Clinical Evaluation" until June 30. In addition, a public meeting to discuss the draft will be held March 26 and 27. Meeting topics include whether patients with stable chronic liver disease should be included in clinical trials. FDA recommends in the draft guidance that firms enroll patients with pre-existing liver disease in at least Phase III clinical trials, especially if the drug might eventually be used in such patients. In comments submitted by the original closing date of Dec. 24, industry requested more clarification on how such patients should be included (1"The Pink Sheet," Feb. 18, 2008, p. 21)

FDA re-opens the comment period for the draft guidance "Drug-Induced Liver Injury: Premarketing Clinical Evaluation" until June 30. In addition, a public meeting to discuss the draft will be held March 26 and 27. Meeting topics include whether patients with stable chronic liver disease should be included in clinical trials. FDA recommends in the draft guidance that firms enroll patients with pre-existing liver disease in at least Phase III clinical trials, especially if the drug might eventually be used in such patients. In comments submitted by the original closing date of Dec. 24, industry requested more clarification on how such patients should be included (¹ (Also see "Pharma Seeks More Guidance On Drug-Induced Liver Injury" - Pink Sheet, 18 Feb, 2008.), p. 21).