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How The US FDA’s Inspectional Approach Is Shifting For The Post-Pandemic Era

 
• By Shannon Brown

Agency hints of a “hybrid” future of in-person inspections supplemented by alternative tools like remote interactive evaluations.

Toolbox
a fuller post-covid inspections toolbox • Source: Alamy

The US Food and Drug Administration will likely continue to use remote inspection alternatives that emerged during the COVID-19 pandemic in a “hybrid approach” with in-person inspections, not in place of them, says assistant commissioner Elizabeth Miller.

Speaking at the Association for Accessible Medicines’s Generics + Biosimilars conference on 9 November, Miller said that FDA does not intend to replace traditional good manufacturing practice inspections with remote...

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