HALF OF U.S. DEVICE FIRMS INCREASING EUROPEAN DEVICE CLINICALS, HIMA-SPONSORED SURVEY SHOWS; MOST FIRMS MARKET IN EUROPE BEFORE U.S., AND MOST BLAME FDA
This article was originally published in The Gray Sheet
Executive Summary
European device clinical trial programs are being expanded by 87% of U.S. development-stage manufacturers, reflecting "a growing movement to relocate technological capacity overseas," according to a report issued by the Wilkerson Group. Most of these companies say they are moving studies offshore as a result of burdensome FDA regulations.