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How US FDA’s Pharma Quality Office Fared In Pandemic’s Second Year

 
• By Bowman Cox

OPQ Director Kopcha looks back at a year that travel restrictions made especially challenging for application reviews, site surveillance, IT support and sleep. And ahead to new challenges around supply chain transparency and resilience.

Covid-19 restricted travel to Asia
opq found ways around covid-19 travel restrictions • Source: Alamy

The second COVID-19 pandemic year challenged the US Food and Drug Administration’s Office of Pharmaceutical Quality in new ways as it worked to complete increasingly complex chemistry, manufacturing and controls reviews while surveilling global manufacturing infrastructure despite lingering travel restrictions, OPQ director Michael Kopcha said in an interview as the office released its 2021 annual report.

OPQ last year supported seven emergency use authorizations, “a significant effort for us” given the need to operationalize processes for...

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