FDA’s options for staying on track with PDUFA timelines during COVID-19

The COVID-19 pandemic is severely limiting FDA’s ability to conduct in-person pre-approval site inspections, putting the agency’s ability to meet its regulatory timelines at risk. To avoid delays, companies need to prepare to provide all the necessary documentation to answer regulators' questions in lieu of an inspection or be willing to get creative through virtual visits.

Pre-approval site inspections for novel and generic drugs enable regulators to ensure that a company is capable of manufacturing its product and that the data in its regulatory submission are accurate and complete. FDA inspectors typically travel to a manufacturing site, conduct an inspection and review the documentation for the manufacturing process first-hand. ...