US Capitol Capsule: Will PDUFA V be a 'damned if it does, damned if it doesn't' scenario for FDA?
This article was originally published in Scrip
Executive Summary
Instead of being praised for speeding new treatments to patients or advancing medical innovation, the US FDA has increasingly come under sharp criticism for failing to do enough to ensure patient safety, which 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 Pincus.