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Tag Archives: Center for Drug Evaluation and Research
Adverse Event Reports Go Digital Only
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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 [...]
Posted in Regulatory, Safety Also tagged Adverse event, Drug Evaluation and Research, FDA, pharmaceutical industry, U.S. Food and Drug Administration 1 Comment
Woodcock Under Investigation
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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 [...]
Posted in Strategy Also tagged Amphastar, FDA, Food and Drug Administration, Sandoz, U.S. Food and Drug Administration, Wall Street Journal Leave a comment
FDA Panel Calls for Ban on Narcotic/Tylenol Combo Drugs
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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 [...]
Posted in Regulatory, Safety Also tagged acetaminophen, Drug overdose, FDA, Health, liver toxicity, overdose, Paracetamol, percocet, Prescription drug, U.S. Food and Drug Administration, Vicodin 1 Comment
Feds Threaten to Pull ProAmatine for Lack of Postmarket Data (Updated 8/18)