PDUFA priorities

FDA and the pharmaceutical and biotech industries have come to a consensus about the goals for PDUFA reauthorization: developing methods and practices to more comprehensively integrate patient perspectives into regulatory decisions, creating a scientific framework for collecting and interpreting real-world evidence and promoting the use of innovative clinical trial designs.

Regardless of the amount of money industry agrees to pay in user fees, FDA can only make progress on these goals if it overcomes its chronic inability to recruit, hire and retain sufficient numbers of qualified employees...