Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

“Ordered, Intimidated And Coerced”? CDRH Targeted In Misconduct Probe

This article was originally published in The Gray Sheet

Executive Summary

FDA's device center has until Dec. 1 to respond to a Congressional inquiry into allegations of wrongdoing in its pre-market review process

You may also be interested in...



LivaNova Launches RECOVER Trial Of VNS For Depression To Meet CMS CED Requirement

LivaNova's RECOVER trial will randomize about 1,000 patients with treatment-resistant depression to either LivaNova’s vagus nerve stimulation therapy or a sham therapy and follow them for at least a year.

Hamburg: Neither U.S. Nor EU Device Regulation Has It Completely Right

During her final public appearance at the National Press Club, outgoing FDA Commissioner Margaret Hamburg defended her tenure and said she was leaving a stronger FDA than the one she inherited. Asked about the agency's device regulatory process, she said she didn't know if FDA or Europe had struck the right balance but said more work needs to be done.

Retiring Rep. Dingell’s Health Policy Legacy Includes Fierce Oversight Of Device Center

A powerful former Chairman of the House Energy and Commerce Committee, Dingell has been not only a major player in the health care reform fight, but also a vigorous prober of FDA, launching investigations with lasting effects on the device center. The longest-serving member of the House announced his plans to retire at the end of this congressional term.

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT026827

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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