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

Supreme Court Justices Support FDA's Authority To Remedy Fraud Claims

This article was originally published in The Gray Sheet

Executive Summary

Supreme Court Justice Stephen Breyer's comments supporting broad enforcement flexibility for FDA during oral arguments in The Buckman Co. v Plaintiffs' Legal Committee are consistent with his concurring opinion in the 1996 case Medtronic v. Lohr.

You may also be interested in...



Supreme Court Questions Whether 510(k) "Intended Use" Must Be Bona Fide

The "intended use" statement in a 510(k) is "not a factual representation" of how a device will be used on the market, Kenneth Geller, attorney for the Buckman Co., contended before the U.S. Supreme Court Dec. 4.

Italy Round-Up: Mylan And Polifarma Strike Deal, OTC Market Stable, Cholesterol-Lowering Probiotic Launch

The latest news from Italy's OTC and supplements markets, including the latest sales figures, business deals, product launches, ad regulation and local association activities.

UsernamePublicRestriction

Register

MT014240

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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