FDA leader urges team approach to pharma manufacturing processes

摘要

Boston, MA—"Your job is to assure us your process is safe; our job is not to tell you how to manufacture drugs." With that candid exhortation to pharmaceutical developers, Dr. Mo-heb Nasr, director of the FDA's Office of New Drug Chemistry, concluded a keynote address that was among several highlights to the CkanRooms Contamination Control Technology 2005 conference and exhibition, held at the World Trace Center in Boston, Mass., in mid-March.