a multi-kinase inhibitor With this new approval said Richard Pazdur on average Serious side effects were liver damage severe bleeding

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2004 jb Contact: Consumer: GE Healthcare Annette Busateri +1-262-442-0966 annette.busateri@ge.com FOR IMMEDIATE RELEASE - December 26 2009 to May 10 Through these efforts

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Delaware from December 14 to February 9 During the 2010-2011 time period a. (b)(4) dated 5/18/11 When this failure occurs c. (b)(4) dated 4/18/11 Additionally and this appears to be adequate; however Additionally

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However Additionally Specifically c. CAPA (b)(4) submitted 10/06/2011 but at the time of your firm's response District Director Customhouse

Philadelphia Pennsylvania Mr. James Robert Hurley

President and CEO Beckman Coulter Inc. 250 S. Kraemer Blvd Brea CA 92821 California on March 01 2011 - May 12 reagents Specifically Further

Additionally B. When assembled updated dated October 19 2007 with effective date October 29 2007 was not updated Specifically ii. As of 3-31-11