Mallinckrodt plc announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it is deferring action (pending a site inspection) on the Stratatech Biologics License Application (BLA) for StrataGraft®, an investigational allogeneic cellularized scaffold product in development for the treatment of adult patients with deep partial-thickness burns. This is due to COVID-19-related travel restrictions, which are delaying a required manufacturing site inspection. The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), has provided funding and technical support for the continued development of StrataGraft under Project BioShield Contract. The FDA granted the BLA for StrataGraft priority review. Previously, the FDA granted StrataGraft orphan drug status, and it was among the first products designated by the agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act.