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US FDA User Fee Staffing: The Objective Capacity Planning Adjuster Often Needs Subjective Review

 
• By Derrick Gingery

The FDA has overruled the results from its own formula intended to match resource levels with workload every time except once.

workforce management
The capacity planning adjustment has the CBER number of employees about right for drug review activities. • Source: Shutterstock

The drug review program at the US Food and Drug Administration can operate with fewer employees today than three years ago, but according the the agency’s own calculations, the number of staff that FDA needs to add to reach the ideal total is still viewed as largely unattainable.

As part of the annual use fee calculation process, the FDA projects its workload in multiple categories, which are then converted into the number of additional employees that would be...

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