As the science of product development and regulation has grown increasingly complex, the FDA’s human medical product user fee programs have also grown both in the scope of activities and the volume and complexity of submissions. Taken together, this growth has increased the operational demands on the agency.

To help ensure that the agency is making optimal use of its financial resources to maximize its ability to efficiently and effectively deliver on its commitments to the public, the agency committed, under PDUFA VI, BsUFA II and GDUFA II, to develop a resource capacity planning capability and to modernize its time reporting approach. Through the development of these capabilities, FDA will build more systematic, data-driven, and repeatable processes to better understand and anticipate its current and future resource demands. This will enable the agency to more proactively ensure its organizational components are optimally resourced.

Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology (PDF - 1MB)

Independent Evaluation of the PDUFA and BsUFA Resource Capacity Planning Adjustment Methodology (PDF - 508KB)

Resource Capacity Planning and Modernized Time Reporting Implementation Plan (PDF-1.32MB)