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.

COVID-19 coronavirus tape barrier
The pandemic has acted as a barrier to FDA inspections • Source: Alamy

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