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

FDA Chief Counsel Addresses Staff Turnover, Device Bans

This article was originally published in The Gray Sheet

Executive Summary

Staff turnover in FDA's Office of the Chief Counsel is a positive, says the agency's top lawyer Elizabeth Dickinson. The chief counsel also discussed recent device bans, off-label communication policy efforts and the agency’s ongoing transparency initiative at the annual Food & Drug Law Institute conference.

You may also be interested in...



Public Supports US FDA Ban On Electroshock Devices

Electrical stimulation devices are used to discourage harmful behavior at one Massachusetts school. Commenters from a wide range of patient advocacy groups and state organizations wrote to support FDA’s proposed ban on ESDs, saying it’s abusive and ineffective.

In Case You Missed It: Top 10 Gray Sheet Stories In May

Our reporting on a halted Medtronic stent-graft trial was the most popular online story last month in The Gray Sheet. Also attracting significant attention in May: coverage of the big regulatory changes afoot in Europe, and the growing efforts by FDA leadership to push forward with an envisioned "national evaluation system" for devices.

Vascular Solutions Case (Partially) Points Way Forward For Off-Label Marketing

Attorneys involved with a recent court ruling favoring Vascular Solutions believe the verdict might give manufacturers more latitude to engage in truthful, non-misleading, off-label speech. But caution is necessary.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034784

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