Industry, FDA Outline Costs Of New MDUFA Proposals; Quality Management A Strong Focus
This article was originally published in Clinica
Executive Summary
After months of discussing proposals on how to improve FDA's device review process in the next user-fee reauthorization (MDUFA IV), the agency put some hard numbers to how much the proposed measures would cost and how many full-time equivalent positions would be required. In total, the agency puts the price tag of the reforms at $500 million over five years on top of the current user fee base, not taking into account inflation.