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The Approval Drought

Executive Summary

The drug approval drought keeps getting worse. FDA says it approved 20 new products during the year, one of the lowest totals in two decades. In fact, focusing on genuinely innovative medicines, the total was even worse. The good news is that 2006 should be a much better year. But focusing on 2006 misses the point: it's the long-term trend that matters. The hope for a turnaround relies on some leaps of faith. Industry is gambling that advances in drug development science will pay off-even though the first efforts to reap the fruits of the genomics revolution are one reason for the current drought.

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