Resiliency Roadmap Update: US FDA Exceeds FY 2021 Inspection Projections
While better than one its ‘best case’ scenarios, FDA has completed just 31% of 15,514 domestic surveillance inspections planned for FY 2021, applications are still being delayed, and foreign inspections have for the most part yet to be tackled.
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Robert Califf’s first tenure as US FDA Commissioner was decidedly anti-climactic. His return trip – assuming the Senate confirms him – will be potentially transformational: he will be the leader that defines what FDA is after COVID.
Product sampling and remote records requests accounted for most import alerts and drug GMP warning letters over the past year – and may play key role post-pandemic.
The House Appropriations Committee also does not want the agency to become too dependent on alternative inspection tools.