Reactions 1077 - 12 Nov 2005

■ The US FDA and BG Medicine are to collaborateon a project, the Liver Toxicology Biomarker Study, todetermine liver toxicity signs in human drug trials,says the agency. The FDA states that early detection ofpossible safety issues is one of the main aims of theFDA’s Critical Path Initiative to modernise drugdevelopment by ensuring the process is successful,less costly and more predictable. Dr Janet Woodcock,FDA Deputy Commissioner for Operations, says that"liver toxicity is a common reason for drugdevelopment failure" and "this research should yieldimportant benefits" by identifying liver toxicitybiomarkers at the beginning of the developmentprocess.FDA. FDA and Industry to Collaborate on Better Ways to Predict LiverToxicity in Human Drug Trials - Part of FDA’s Critical Path Initiative toModernizing Drug Development. Media Release : 2 Nov 2005. Availablefrom: URL: http://www.fda.gov 809056451

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Reactions 12 Nov 2005 No. 10770114-9954/10/1077-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved