PDUFA law's breakthrough therapies designation could spur investment
This article was originally published in Scrip
Executive Summary
While the essential function of the Food and Drug Administration Safety and Innovation Act (FDASIA) was to reauthorize the Prescription Drug User Fee Act for five more years – or PDUFA V – the package includes several measures focusing on innovation, improving communication between regulators and industry and advancing the US drug development process, said Dr John Jenkins, director of the US FDA's Office of New Drugs.