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Can PDUFA V solve biopharma's R&D productivity crisis?

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Executive Summary

There is a certain irony that the one issue that is actually garnering broad bipartisan support on Capitol Hill this year – user fees – is something that involves the US FDA, a "regulatory agency that, frankly, has not been the focus of a lot of affection over many years from Congress and others," said a beaming FDA Commissioner Dr Margaret Hamburg.

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