Mallinckrodt provides regulatory update on StrataGraft

Mallinckrodt Pharmaceuticals

12 February 2021 - Mallinckrodt today announced that the U.S. FDA has informed the Company that it is deferring action (pending a site inspection) on the Stratatech biologics license application for StrataGraft, an investigational allogeneic cellularised 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.

Read Mallinckrodt Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Outcome , US , Dossier , Cellular therapy