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

Acclarent Whistleblower Says Device Off-Label Marketing Too Risky

Executive Summary

The former device industry sales rep behind the Acclarent off-label marketing case argues against any off-label marketing of devices, saying the 510(k) process and financial motives make it too risky.

You may also be interested in...



US FDA Hears Competing Messages On Off-Label Communications

Over the course of a two-day meeting at FDA headquarters, the agency heard from the medtech industry, which argued for expanding rights to off-label promotion, and consumer groups that worry about the possible impact on the public health. The meeting is intended to inform FDA's comprehensive review of its regulations and policies governing firms' communications about unapproved uses of approved/cleared products.

Acclarent Execs Move To Appeal Off-Label Conviction

Attorneys for former Acclarent executives William Facteau and Patrick Fabian have filed a request that their convictions on off-label marketing charges either be set aside or that they be granted a new trial, citing other recent off-label trials and misconduct by the government.

Addition to Quest Alzheimer's Suite Looks For Biomarker P-Tau217

The test is being integrated into Quest’s AD-Detect portfolio for assessing the risk of Alzheimer’s. It is the third p-tau217 test to make news this month, after new breakthrough designations for Quanterix and Roche and Eli Lilly.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT104104

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