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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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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.

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

New molecular entity approvals dipped in 2010 and Innovative Commercial Therapies dropped even more sharply. Add to that a significant drop in filings in 2010 and it is hard to be optimistic about a turnaround in approval numbers any time soon.

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