What’s new?

• It is clarified under which circumstances a pending application may be approved when a physical inspection cannot be conducted
• Detailed information is given regarding the issue of "complete response (CR) letters" in case of remote inspections. Two scenarios are outlined, one with GMP deficiencies being recognised or without.
• The action FDA will take if a decision on an application has to be deferred due to insufficient information for conducting a remote inspection is described.

The roadmap
With an overall inspection backlog the FDA is taking additional steps to bridge the gap. A “resiliency roadmap” addresses the various challenges. It details how the pandemic has delayed all but the most important and high priority inspections last year with a huge amount of inspections still open. Furthermore current and future activities are layed out. With this roadmap a more consistent state of operations shall be achieved.

Source:

FDA: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency