FDA Wants Better PDUFA Fees-Goals Alignment, Predictability
This article was originally published in Scrip
Executive Summary
While industry wants better integration of the patient perspective into US drug development and regulatory decision-making and an enhancement of the scientific expertise, processes and tools regulators use, the FDA said it would like to see greater alignment of the fee structure with its public health goals and improved predictability of the dollar amounts under the next round of the Prescription Drug User Fee Act – PDUFA VI – according to the minutes from the first meeting to negotiate terms.