FDA Focuses on Postmarket Safety in 2011 Budget Request

The FDA is emphasizing postmarket drug safety in its fiscal 2011 budget request, with the agency’s Sentinel Initiative among the areas set to benefit from the increased funding. The agency is seeking an increase of $28 million for postmarket drug safety activities, with nearly all of the additional funding being used for CDER’s center activities and an increase of $24,000 for field activities. About $72 million, or 50 percent of the increase for center activities, would come from user fees — $18 million more than current user fees generate, as well as a new $10 million user fee specifically for postmarket safety activities.
Drug Industry Daily