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FDA China Office Will Be Test Of International Diplomacy, Intra-Agency Politics

Executive Summary

FDA's opening of a China Office will be an early test of how the agency handles the challenges of globalization, not only in working with foreign governments, but in restructuring itself to operate on a world-wide footing

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Legal and Regulatory Round-up: TriCor Suit Settles, Seroquel Suits Are Tossed, FDA Opens New Post

Abbott settles TriCor antitrust suit with states: Abbott and its French marketing partner Fournier agreed to pay 24 states and the District of Columbia $22.5 million to settle a suit claiming they blocked generic competition for the cholesterol drug TriCor (fenofibrate) by making minor changes in the formulations to prevent generic substitutions. The 2008 suit also alleged that the companies filed baseless patent infringement suits against Teva and Impax to trigger a 30-month automatic stay of approval (1"The Pink Sheet," March 24, 2008). The Florida Attorney General's Office led the litigation. Last month Abbott settled its patent infringement suit against Teva, allowing Teva to begin marketing its generic fenofibrate in March 2011 (2"The Pink Sheet," Dec. 7, 2009). Direct purchasers had filed a similar TriCor antitrust suit against Abbott, which the company settled in 2008 for $184 million

Legal and Regulatory Round-up: TriCor Suit Settles, Seroquel Suits Are Tossed, FDA Opens New Post

Abbott settles TriCor antitrust suit with states: Abbott and its French marketing partner Fournier agreed to pay 24 states and the District of Columbia $22.5 million to settle a suit claiming they blocked generic competition for the cholesterol drug TriCor (fenofibrate) by making minor changes in the formulations to prevent generic substitutions. The 2008 suit also alleged that the companies filed baseless patent infringement suits against Teva and Impax to trigger a 30-month automatic stay of approval (1"The Pink Sheet," March 24, 2008). The Florida Attorney General's Office led the litigation. Last month Abbott settled its patent infringement suit against Teva, allowing Teva to begin marketing its generic fenofibrate in March 2011 (2"The Pink Sheet," Dec. 7, 2009). Direct purchasers had filed a similar TriCor antitrust suit against Abbott, which the company settled in 2008 for $184 million

Solution For Global GMP Oversight Elusive, FDA Commissioner Says

Margaret Hamburg says FDA will have to share inspections with sister regulatory agencies abroad - but acknowledges that the problems will not be completely solved during her tenure.

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