FDA Sees Another Submission Decrease In FY 2011, Increases Application Fees
The figures continue a recent trend of decreases in fee-paying full application equivalents but were not as low as had been estimated.
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PDUFA, Biosimilar Application Fees To Rise 10.7%; FDA’s Workload Adjuster Needs Work
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.
FDA Drug Review Costs Rise, But Personnel Spending Flattens
Less than 60% of the total spending on reviews was attributed to employee compensation and benefits in FY 2011. FDA says it is normal, but the figure is lower than costs seen in recent years.
FDA Spending Less Time On INDs, More On NDAs and BLAs
Five-year averages used in calculations of FY 2013 user fee rates show a decrease in time devoted to INDs and an increase in time spent on NDAs and BLAs. The average submission volume in both categories still increased.