Drug hepatotoxicity from a regulatory perspective.
This article summarizes problems of drug-induced liver injury (DILI), as seen from the perspective of the Food and Drug Administration (FDA). After brief consideration of the scope of FDA activities and processes of new drug development and review for possible approval of products for clinical use and marketing, some of the perceived current problems in detection, confirmation, close observation, differential diagnosis, and follow-up of cases of possible DILI in controlled clinical trials are described. Readers are invited to consider possible solutions to the many problems of DILI, propose ways to support research in the field, and keep abreast of progress by visiting the web site at www.fda.gov/cder/livertox.
Senior
John R
JR
Center for Drug Evaluation and Research, Food and Drug Administration, Federal Research Center at White Oak, Building 22:3482, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA. john.senior@fda.hhs.gov
D056486:Chemical and Drug Induced Liver Injury; D002986:Clinical Trials as Topic; D015195:Drug Design; D004341:Drug Evaluation; D004335:Drug and Narcotic Control; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration