Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Opening of Comment Period for Future Revision of Guidance Dated July 2009; Public Conference

概要

The Food and Drug Administration (FDA) is opening a comment period for submission of suggestions for revising the guidance for industry published in the Federal Register July 30, 2009, entitled "Drug-Induced Liver Injury: Premarketing Clinical Evaluation." In addition, FDA, along with the American Association for the Study of Liver Diseases (AASLD) and the Pharmaceutical and Research Manufacturers of America, is sponsoring a public conference to be held on March 24 and 25, 2010, to discuss and debate issues contained in the published guidance document. The purpose of the conference is to consider the effect of the recommendations in the guidance since its publication, and to seek suggestions for future revisions that will incorporate the views expressed.