Pharma Seeks More Guidance On Drug-Induced Liver Injury
Executive Summary
Although major pharmaceutical companies do not appear to be rejecting the proposal in FDA's draft guidance on drug-induced liver injury that trials enroll patients with preexisting liver disease, according to comments submitted on the draft, the companies would like to see more clarification on how such patients should be included
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Drug-Induced Liver Injury Workshop Offers More Questions Than Answers
To fully understand an experimental drug's potential for liver toxicity, clinical trials should be better designed to reflect real-world populations, including patients with liver disease, but neither FDA nor experts from industry and academia at a recent workshop on the topic were able to provide many answers on how to do so safely
Drug-Induced Liver Injury Workshop Offers More Questions Than Answers
To fully understand an experimental drug's potential for liver toxicity, clinical trials should be better designed to reflect real-world populations, including patients with liver disease, but neither FDA nor experts from industry and academia at a recent workshop on the topic were able to provide many answers on how to do so safely
Liver injury draft guidance update
FDA re-opens the comment period for the draft guidance "Drug-Induced Liver Injury: Premarketing Clinical Evaluation" until June 30.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 FDA recommends in the draft guidance that firms enroll patients with pre-existing liver disease in at least Phase III clinical trials, especially if the drug might eventually be used in such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)