HBW 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

Ibuprofen ‘Regulatory History’ Pre-empts Failure-To-Warn Claims In State Court – CHPA

This article was originally published in The Tan Sheet

Executive Summary

FDA regulations and decisions on ibuprofen labeling indicate the agency would not approve warnings plaintiffs seek for Motrin, preventing J&J/McNeil from making the changes without violating federal law, which pre-empts state laws, according to CHPA’s amicus brief in the firm’s appeal of a verdict in Massachusetts.

You may also be interested in...



In Brief

Jury orders McNeil to pay $63M in TEN suit; Marshals seize Globe All Wellness products; USP forms supplement adulteration panel; FDA warnings for GMPs flow; Hurricane Sandy impact knocks GNC revenue; Icahn takes Herbalife stake; U.K. shuts down melatonin ad.

High Court’s Wyeth v. Levine Ruling Returns Pre-Emption Status Quo

The Supreme Court's ruling in Wyeth v. Levine dashes pharmaceutical industry hopes for broad protection from state product liability lawsuits, but is not expected to trigger a sea-change in current industry operations

US Proposed OTC Hearing Aid Rule Inspired Soundly Founder To ‘Make This Process Easier’

In recent interview, CEO Blake Cadwell talked about Soundly’s business model and outlook for hearing aid marketplace after FDA's pending publication of rule aiming to make the devices more accessible. Firm since June has offered online testing and advice for customers about hearing aids best suited for their needs.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

RS123891

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