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 Denies WLF Petition To Allow Dissemination Of Off-Label Information

This article was originally published in The Gray Sheet

Executive Summary

Dissemination of journal reprints representing off-label use of a device or drug will not by themselves trigger FDA enforcement action against a manufacturer, according to the agency

You may also be interested in...



FDLI Off-Label Promotion Discussion Ventures Into “Abstract” Territory

Companies should request records of FDA correspondence related to premarket notification when weighing the purchase of another firm's 510(k), attorney Jeffrey Gibbs advised during a Sept. 13-14 Food & Drug Law Institute meeting in Washington, D.C

FDLI Off-Label Promotion Discussion Ventures Into “Abstract” Territory

Companies should request records of FDA correspondence related to premarket notification when weighing the purchase of another firm's 510(k), attorney Jeffrey Gibbs advised during a Sept. 13-14 Food & Drug Law Institute meeting in Washington, D.C

WLF Answers Democrats In First Amendment Off-Label Promotion Debate

Off-label information is not "inherently misleading," and consequently FDA should ease restrictions for disseminating it, the Washington Legal Foundation asserts in its response to congressional Democrats' interpretation of First Amendment case law

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT016047

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