FDA Guidance on Drug-Induced Liver Injury Details Criteria to Determine Severity

摘要

The FDA issued a guidance for drug developers that details how laboratory measurements for use in clinical trials to assess a product's potential to cause severe drug-induced liver injury (DILI) can be obtained and evaluated to distinguish signals of potential severe injury from signals without that potential.rnLiver damage is the most frequent safety-related cause for pulling drugs from the market, according to the guidance. Posted Thursday on the agency's website, it does not address issues of pre-clinical evaluation or postapproval detection and assessment of DILI, and updates a draft issued in 2007 (WDL, Oct. 29, 2007).