Monday, November 08, 2010

J&J, Glaxo Actions in Puerto Rico Spark FDA Oversight Inquiry in Congress - Bloomberg

Johnson & Johnson’s and GlaxoSmithKline Plc’s drug-safety missteps sparked a Congressional investigation of U.S. regulators overseeing manufacturing in Puerto Rico.

Representatives Darrell Issa and Edolphus Towns sent a letter today to Food and Drug Administration Commissioner Margaret Hamburg, asking for inspection records and warning letters from the past decade, “to better understand whether FDA Puerto Rico is fulfilling its regulatory responsibility.” Issa, a California Republican, and Towns, a New York Democrat, lead the House Committee on Oversight and Government Reform.

Posted via email from Jack's posterous

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