Drug-Induced Liver Injury Workshop Offers More Questions Than Answers
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA co-hosts a two-day conference to address questions raised by pharmaceutical company comments on the agency's draft guidance on studying drug-induced liver injury. While FDA, industry and academics agreed that patients with underlying liver disease should be included in trials in order to better test a real-world population, there is no consensus on how to do so safely