Complete Response Letters In Lieu Of Inspections: What To Expect During COVID-19

The US Food and Drug Administration confirmed in a 19 August guidance document that it will generally issue complete response letters to sponsors when it has concerning information about the manufacturing facilities listed in their product marketing applications but cannot conduct a timely pre-approval inspection, or PAI, due to the pandemic.

Alternatively, the agency said if it lacks adequate information to decide whether a facility is acceptable, it may defer action on the