Draft Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Reopening of Comment Period; Public Conference

Streszczenie

The Food and Drug Administration (FDA) is reopening until June 30, 2008, the comment period for the draft guidance for industry entitled "Drug-Induced Liver Injury: Premarketing Clinical Evaluation," published in the Federal Register of October 25, 2007 (72 FR 60681). FDA is also announcing a public conference entitled "Detecting and Investigating Drug-Induced Liver Injury During Clinical Trials." FDA is cosponsoring the conference with the American Association for the Study of Liver Diseases (AASLD) and the Pharmaceutical and Research Manufacturers of America. The purpose of the conference is to discuss the draft guidance and to solicit additional input on the issues and questions presented in this document.