Tag Archives: Center for Drug Evaluation and Research

Adverse Event Reports Go Digital Only

By George Koroneos | Published: August 20, 2009
Image via Wikipedia FDA, this morning, walked media through its proposed regulations requiring that pharma companies submit post-market adverse event reports through an electronic format. This is being done to help eliminate time and cost wasted on paper submissions. “This change will enhance FDA’s ability to rapidly identify new safety concerns and share safety information with [...]
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Woodcock Under Investigation

By George Koroneos | Published: August 12, 2009
Image by Getty Images via Daylife An FDA director has come under fire by a generics firm claiming that the director of the Center for Drug Evaluation and Research favored a competitor in a wanton act of conflict of interest. The Wall Street Journal this morning broke the story that Janet Woodcock is under investigation by [...]
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FDA Panel Calls for Ban on Narcotic/Tylenol Combo Drugs

By George Koroneos | Published: July 1, 2009
Image via Wikipedia A joint committee of three FDA advisory groups voted on Tuesday to recommend the elimination of prescription combination drugs containing acetaminophen due to a spike in instances of liver-induced toxicity. The panel of experts, physicians, and regulators voted 20 to 17 in favor of banning acetaminophen combo drugs such as Vicodin and Percocet. They [...]
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