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PDUFA, Biosimilar Application Fees To Rise 10.7%; FDA’s Workload Adjuster Needs Work

 
• By Sue Sutter

Facility and product user fees will increase by more than 5% for fiscal year 2014; FDA calculated the fees using a revised workload adjuster because the previous method failed to reflect increasing complexity of the drug review process.

Prescription drug application user fee rates will jump more than 10% in fiscal year 2014 under a revised method for calculating fees that excludes an FDA workload complexity measure deemed faulty.

FDA announced the FY 2014 fee rates under the Prescription Drug User Fee Act, Biosimilar User Fee Act and Generic Drug User Fee Act on Aug

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