The World of Separation Science WCBP '06: The Science is Much Better Than the

摘要

As is the custom, the WCBP '06 meeting (where "WCBP" used to stand for "well characterized biological products," but now is nearly meaningless as an acronym started with a report from a senior FDA official. This year, it was from Steven K. Galson, M.D., MPH, Director of the Center for Drug Evaluation and Research (CDER), FDA (Rockville, MD). Only 20 new molecular entities were approved in 2005, which is down from 26 in 2004. Of the 20, 15 received priority approval.