Pink Sheet 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


"Fraud on FDA"

Executive Summary

Supreme Court finds state law claims based on "fraud on FDA" in device premarket submissions could have adverse consequences on the regulatory balance. The Feb. 21 decision in favor of Buckman Company reverses a lower court ruling in Buckman v. Plaintiffs Legal Committee. The Pharmaceutical Research & Manufacturers of America filed an amicus brief in support of Buckman arguing that the lower court's decision, unless reversed, would improperly permit states to second-guess FDA approval decisions (1"The Pink Sheet" Dec. 11, 2000, p. 15)

You may also be interested in...

Buckman Claims Could Undermine FDA Approval Decisions - Justice Scalia

FDA's premarket clearance authority could be undermined if states are given power to remedy "fraud on FDA" claims, Supreme Court Justice Antonin Scalia suggested during Dec. 4 arguments for Buckman v. Plaintiffs' Legal Committee.

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials




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