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BEXTRA – No Different Than Vioxx ( August 2005 )
On April 7, 2005, the U.S. Food and Drug Administration (FDA) asked Pfizer, Inc., to remove its Cox-2 inhibitor, BEXTRA, from the market. Pfizer recalled BEXTRA, citing the potential for increased risk of heart attack and stroke. While sound evidence exists that BEXTRA also causes severe forms of skin disorders, including Stevens Johnson Syndrome (SJS) in patients taking the drug, Pfizer denied the recall was based upon these adverse skin conditions. -
Pfizer/Pharmacia Merger--The Biggest Just Got Bigger ( May 2003 )
The FTC recently approved the merger of Pfizer Inc. and Pharmacia Corporation. Pfizer is purchasing Pharmacia for an estimated $60 billion solidifying its position as the world's largest pharmaceutical company. Pfizer will control 11 percent of the world's pharmaceutical market, up from 8 percent, with annual revenue estimated to increase to $46 billion from $32 billion. -
The Next Mass Tort? ( November 2000 )
This article reviews the potential next mass tort in the nutraceuticals market. -
FDAMA Provision Restricting Dissemination of "Off-Label Information" Held Unconstitutional ( January 2001 )
In July 1999, the U.S. District Court for the District of Columbia issued the third in a series of decisions in Wa. -
Increased FDA Scrutiny of Clinical Investigators May Signal Trouble for Researchers and Company Sponsors ( January 2001 )
Enforcement statistics suggest an increase in violative conduct identified by the Agency in its oversight of clini. -
FDA, Off-Label Use, And Informed Consent: Debunking Myths and Misconceptions ( August 1998 )
This article reviews the FDA's regulatory process of getting a drug to market and then outlines the Food & Drug Administration Modernization Act of 1997and how that Act will affect informed consent and off-label use. -
Off-label Provisions Of The Food And Drug Modernization Act Found Unconstitutional ( August 1999 )
This Alert discusses case law and legislation regarding off-label provisions of the food & drug administration. -
FDA: Too Little Too Late ( August 1999 )
Claims resulting from latex exposure in the workplace continue to crowd the court dockets at epidemic levels. -
What's The "Skinny" on Fen-Phen? ( April 1999 )
By the time fenfluramine and its sister drug, dexfenfluramine were recalled, an estimated 6 million Americans and a. -
Year 2000 Law Bulletin, March 1999 ( March 1999 )
This bulletin provides information about the potential effects of the Y2K problem on medical devices and the health industry.
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