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The Prescription Drug User Fee Act (PDUFA) pressures the FDA to review drugs on too-tight deadlines and encourages the agency to put the public’s interest second to the industry’s, witnesses at a House subcommittee hearing said.
FDA staff say the Critical Path Initiative (CPI) is in trouble, with insufficient funding leaving employees working on the program during their off hours.
Improved drug safety is foremost in the FDA’s Prescription Drug User Fee Act (PDUFA) proposal that seeks new authority and more than $29 million in additional fees specifically to improve its postmarket safety surveillance.
Improved drug safety is foremost in the FDA’s Prescription Drug User Fee Act (PDUFA) proposal that seeks new authority and more than $29 million in additional fees specifically to improve its postmarket safety surveillance.
Pending industry user fee reauthorization will strongly shape the FDA's likely effort to use regulatory action to preempt legislative fixes for a number of issues in the next Congress, sources say. Read More
Pending industry user fee reauthorization will strongly shape the FDA’s likely effort to use regulatory action to preempt legislative fixes for a number of issues in the next Congress, sources say.
The FDA believes its funding will increase in 2008 through
negotiations over the Prescription Drug User Fee Act (PDUFA) but remains concerned that flat funding levels in 2007 will undermine a number of agency programs.
The FDA believes its funding will increase in 2008 through negotiations over the Prescription Drug User Fee Act (PDUFA) but remains concerned that flat funding levels in 2007 will undermine a number of agency programs.
A coalition of pharmaceutical and biotechnology companies and associations is preparing to lobby Congress for increased FDA funding because of concerns about the agency’s increasing reliance on user fees.
A coalition of pharmaceutical and biotechnology companies and associations is preparing to lobby Congress for increased FDA funding because of concerns about the agency’s increasing reliance on user fees.