LI-COR Biosciences Submits Active Substance Master File for IRDye 800CW to European Regulatory Authorities and Registers Drug Master File with US FDA
9/2/2011 9:09:29 AM
LINCOLN, Neb.--(BUSINESS WIRE)--LI-COR Biosciences announces an Active Substance Master File (ASMF) for IRDye 800CW N-succidimidyl ester is on record with European regulatory authorities in support of a clinical trial testing a targeted agent for optical imaging-assisted surgery. In addition, a Drug Master File has been registered with the United States Food and Drug Administration in anticipation of similar clinical trials in the U.S. The dye is manufactured under GMP and is the subject of a published toxicity study.