The Approval Rebound Begins
This article was originally published in RPM Report
Executive Summary
The Center for Drug Evaluation & Research approved one more new molecular entity in 2009 than it did in 2008. But dig a little deeper and there is promising evidence that the approval trend is on an upward trajectory. It is far too early to declare a turnaround, but at least there are signs that the FDAAA era is translating into more products making it to market.
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FDA has been perceived by drug developers as a regulator obsessed with drug safety. But recent cases show serious safety concerns aren’t holding back new products: efficacy has been the deciding factor for approval.
The Era of Drug Efficacy
FDA has been perceived by drug developers as a regulator obsessed with drug safety. But recent cases show serious safety concerns aren’t holding back new products: efficacy has been the deciding factor for approval.
Another Disappointing Year for Drug Approvals
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