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The way is clear for PDUFA V but can it solve US biopharma's R&D productivity crisis?

This article was originally published in SRA

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 Food and Drug Administration, 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 Margaret Hamburg1.

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