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FDA Spending Less Time On INDs, More On NDAs and BLAs

 
• By Derrick Gingery

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.

FDA’s workload estimates show the agency has been spending less time dealing with INDs, but with policy changes taking effect that will require more work with sponsors during that stage, that outlook should change.

Some of the agency time has shifted to NDAs and BLAs, as it faces more pressure to complete reviews faster.

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