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

Off-Label Dissemination Promotes Illegal Activity - FDA WLF Appeal

This article was originally published in The Gray Sheet

Executive Summary

Dissemination of information on off-label uses of medical devices and drugs is not constitutionally protected free speech because it is intended to promote illegal activities, FDA argues in its appeal of a lower court's decision in the Washington Legal Foundation v. Henney case.

You may also be interested in...



US FDA Allows Dry-Heat Systems For Mask Deep Cleaning

The guidance document allows manufacturers to promote their dry-heat systems for mask bioburden reduction if they meet certain standards.

COVID-19: CMS Allowing Hospital-Level Payments For Home-Based Care

The US Medicare agency is letting ambulatory surgical centers and patient homes be reimbursed as in-patient hospitals for patient care purposes during the pandemic.

Piqray - What EU Regulators Saw And What They Wanted

The European public assessment report for Novartis's advanced breast cancer therapy, Piqray (alpelisib), includes some interesting insights into what EU regulators are looking for in drug company clinical trials. 

UsernamePublicRestriction

Register

OM004559

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