Lexology February 2, 2023
As the COVID-19 public health emergency has slowly receded from the headlines, the U.S. Food and Drug Administration (“FDA”) and its enforcement partner, the Department of Justice (“DOJ”), have spent much of the past year focused on traditional areas of enforcement, including manufacturing practices, product safety, data integrity, and the removal of unapproved products from the market. Although we expect enforcement action in connection with COVID-19-related fraud to continue, FDA appears highly motivated to clear its inspection backlog and ramp up enforcement for manufacturing and data integrity-related deficiencies. Industry stakeholders would be well advised to ensure their compliance infrastructures are appropriately focused on core FDA issues like product quality and ensuring...
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