The US Food and Drug Administration is “actively working” on addressing barriers to inspections caused by the COVID-19 pandemic that have resulted in delays to agency action on products including multiple biosimilars, the regulator has told Generics Bulletin.
FDA Will Take Action On Biosimilars Delayed By Inspection Lag
US Agency Says It Is ‘Actively Working’ On Addressing Outstanding Inspections
With multiple US biosimilar applications held up by the FDA’s inability to conduct necessary inspections in the context of the COVID-19 pandemic, the agency tells Generics Bulletin that it is “actively working” on a solution.
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