Drug facility pre-approval inspections are required to grant a complete response letter from the FDA to get a new drug application approved. FDA understands that some facilities which are located in regions impacted by COVID-19 may have some travel restrictions and cannot be inspected prior to granting such approval. In such situations FDA intends to continue using other tools and approaches such as requesting existing inspection reports from other trusted foreign regulatory partners through mutual recognition and confidentiality agreements as well as requesting records and other information directly from the facilities and other entities...