Are US pre-filing user fees in pharma's future?
This article was originally published in SRA
Executive Summary
When the US Food and Drug Administration negotiates with brand-name manufacturers on the next round of the Prescription Drug User Fee Act - PDUFA VI - the agency may try to find a way of receiving some payments earlier on in the drug development process, said Dr Gillian Woollett, senior vice president at Washington-based analysis and consultancy firm Avalere Health.