PMA Slowdown To Persist In ’04, McClellan Says; User Fee Hikes To Follow?
This article was originally published in The Gray Sheet
FDA expects the rate of new product applications to continue declining for the foreseeable future, despite a series of review cycle improvement initiatives begun in January
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A third-party audit of FDA review costs and workload data associated with the Medical Device User Fee & Modernization Act may be in the offing
FDA's revised target for medical device review times would yield a nearly 10% reduction in total FDA days for half the premarket applications approved between fiscal 2005 and 2007
PMA submission trends over the next 12 months will help determine whether device user fees in fiscal 2005 continue to rise at the FY 2004 rate