Forty-Eight US FDA Drug Application Decisions Delayed By Pandemic's Deferred Inspections

US FDA 'resilience' report charts how inspection backlog grew and impacted approvals and compliance follow-up. 

FDA Food Inspectors
how FDA inspections got backed up during COVID-19

The US Food and Drug Administration says 48 decisions on human drug applications remain delayed by the difficulty of inspecting or assessing manufacturing facilities during the pandemic, including six considered to be mission-critical cases.

The agency has scheduled those mission-critical inspections for later this fiscal year, which ends 30 September. 

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