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Surge In Applications Triggers User Fee Inflation

 
• By Derrick Gingery

With full NDA and BLA submissions to FDA now growing faster than INDs and supplements, user fees are increasing more rapidly as well.

In addition to being burdened with more meetings and work during most new drug reviews, FDA staff also is seeing more applications, which is helping increase user fees.

The average number of NDAs and BLAs the agency reviewed increased substantially between 2010 and 2015, according to the workload adjustment used to calculate FY 2016 prescription drug user fees.

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