As waves of fear gripped the world due to the COVID-19 pandemic, travel restrictions in 2020 swiftly brought profound changes to the US Food and Drug Administration’s enforcement program. The changes continue today and will reverberate in the years ahead.
Preparing For The Return Of US FDA Inspections
Compared to FY2019, FDA data show agency inspections of OTC and Rx drug manufacturing facilities in FY2020 fell 60%. As pandemic continues in FY2021, inspection rate will remain depressed, and it remains unclear how the agency will reduce the backlog without resorting to remotely conducted inspections.
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