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Courts Struggling to Apply FDA Preemption Decision01/29/2010 When the U.S. Supreme Court ruled in Riegel v. Medtronic that many state tort claims
against manufacturers of FDA-approved (premarket approval) medical devices are preempted by federal law, it didn’t
give clear guidance on which types of cases may still proceed in litigation. As a result, lower federal courts are struggling
with the issue and have reached varying conclusions, according to an analysis by attorneys Steven Ellison, Peter Goss, and Joe Wearmouth (all Faegre and Benson). Read More...
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Pfizer Scraps Lyrica sNDA in Reduced Pipeline01/27/2010 Pfizer says it has withdrawn a supplemental
NDA for a new indication for Lyrica (pregabalin) for adjunctive treatment of generalized anxiety disorder. The company made
the announcement in an update on its pipeline reduction resulting from its acquisition
of Wyeth last year. Already approved for treating partial seizures, pain following the rash of shingles and pain associated
with diabetic neuropathy, Lyrica in 2007 became the first drug approved to treat fibromyalgia, a disorder characterized by
pain, fatigue and sleep problems. Read More ...
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FDA’s Culture is Purposefully Pro-industry1/21/2009 [Commentary by Jim Dickinson*] Enforcement is up, but despite an apparent rising tide of industry worry about what
this means, the regulatory culture deep inside FDA now continues to be far more pro-industry than it has been at any time
since my close-up observations began in 1975. Few today remember the battles industry waged against strident, Goddard-inspired, demanding drug reviewers like cardio-renal chief John Harter and against the notorious “drug lag”
in which the U.S. seemed to always be the last country to approve every new drug. Carter Administration chief counsel Nancy
L. Buc frequently extolled the virtues of the “healthy tension” that was supposed to exist in the arm’s
length relationship between regulator and regulatee. ... Read More
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