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5:41 PM
Mar 27, 2008
 |  BC Extra  |  Politics & Policy

FDA refutes PDUFA safety study

FDA officials on Thursday criticized a study published in The New England Journal of Medicine that reports a statistically significant association between drug approvals near PDUFA deadlines and post-market safety problems.

The paper, by Daniel Carpenter of Harvard University and colleagues, concluded that drugs approved in the...

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