No conflict, but FDA's head drug official steps aside from an approval process
linkurl:Janet Woodcock,;http://www.fda.gov/AboutFDA/CentersOffices/ucm193984.htm director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), has recused herself from the approval process for two competing blood-thinning drugs that mimic the anticoagulant with a troubled recent past, heparin. The FDA linkurl:claimed;http://www.baltimoresun.com/entertainment/michael-jackson/sc-dc-fda04-20100204,0,7396350.story that Woodcock did not have a conflict of interest regarding the approvals, though she enlisted the linkurl:help;http://content.nejm.org/cgi/content/abstract/358/23/2457 of scientists from one of the competing drug makers, Momenta Pharmaceuticals, to investigate tainted supplies of heparin from China in 2008. According to the FDA, she stepped aside voluntarily, and the US Department of Health and Human Services has halted an investigation into allegations of a conflict lodged by Amphastar Pharmaceuticals -- the firm that's competing with Momenta for approval of their heparin generic.
Reviewers to NIH: Huh?
The US National Institutes...
linkurl:Janet Woodcock,;http://www.fda.gov/AboutFDA/CentersOffices/ucm193984.htm director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), has recused herself from the approval process for two competing blood-thinning drugs that mimic the anticoagulant with a troubled recent past, heparin. The FDA linkurl:claimed;http://www.baltimoresun.com/entertainment/michael-jackson/sc-dc-fda04-20100204,0,7396350.story that Woodcock did not have a conflict of interest regarding the approvals, though she enlisted the linkurl:help;http://content.nejm.org/cgi/content/abstract/358/23/2457 of scientists from one of the competing drug makers, Momenta Pharmaceuticals, to investigate tainted supplies of heparin from China in 2008. According to the FDA, she stepped aside voluntarily, and the US Department of Health and Human Services has halted an investigation into allegations of a conflict lodged by Amphastar Pharmaceuticals -- the firm that's competing with Momenta for approval of their heparin generic.
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