User Fee Program Faces Challenges As Industry Presses For MDUFMA Funding
This article was originally published in The Silver Sheet
Executive Summary
INDUSTRY ASSOCIATIONS ARE INCREASING PRESSURE ON CONGRESS to appropriate the premarket review funds authorized by MDUFMA, with a projected 18% jump in PMA user fees in fiscal 2005 fueling their determination. In related developments, questions are arising about the fate of the user fee program as lawmakers gear up to extend the system past 2005. At FDA, the device center continues to hone its premarket review processes with an eye toward meeting MDUFMA performance goals, which kick in next year....