FDA Metric: FDA TRACK and MDUFA III Independent Assessment
WHAT: Agency-wide performance management system
HOW: Monitors FDA programs through key performance measures and projects
WHEN: Quarterly
WHAT: independent assessment of CDRH’s premarket review program
WHO: Booz/Allen/Hamilton
HOW: Process improvements to promote predictable, efficient, and consistent premarket reviews (Phase 1), FDA’s implementation Phase 1 recommendations (Phase 2)