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Will PDUFA V be a 'damned if it does, damned if it doesn't' scenario for US FDA?

This article was originally published in SRA

Executive Summary

Instead of being praised for speeding new treatments to patients or advancing medical innovation, the US Food and Drug Administration has come in for sharp criticism for failing to do enough to ensure patient safety, and this has resulted in the agency shifting to a more cautious, risk-averse posture in recent years, asserted Jonathan Leff, managing director of New York-based equity investment firm Warburg Pincus1,2.

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