Are FDA pre-filing user fees in pharma's future?
This article was originally published in Scrip
Executive Summary
When the FDA negotiates with brand-name manufacturers for the next round of the Prescription Drug User Fee Act – PDUFA VI – the agency may try to finagle a way to receive some payments up front, said Dr Gillian Woollett, senior vice president at Washington-based analysis and consultancy firm Avalere Health.