Prescription drug user fee act and its influence on review time and budget

Abstract

Before enactment of this act review time for a new drug application is unacceptably long, to overcome this problem PDUFA act was enacted by United States federal government. PDUFA act was legislated in 1992 and for every five years, it was amended with specific goals. PDUFA act is last amended as FDA Safety and Innovation Act in 2012. PDUFA act allowed FDA to collect three types of user fees from manufacturers, they are application fee, establishment fee and drug product fee. After the introduction of this act most of the times it reached its targets of review time and budget.