IMPROVED IDE SUBMISSION RATE REFLECTS HEALTHY U.S. R&D ACTIVITY, BURLINGTON SAYS; FDA APPROVING "ALMOST HALF" OF IDEs DURING FIRST REVIEW CYCLE
This article was originally published in The Gray Sheet
Executive Summary
A resurgence in investigational device exemption submissions in FDA's fiscal year 1995 reflects a healthy U.S. research and development base and refutes industry contentions that FDA premarket requirements are driving clinical trials offshore, Bruce Burlington, director of the agency's Center for Devices and Radiological Health, said June 7 at the Medical Design & Manufacturing East conference in New York City.