Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT004212

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel