Mallinck­rodt be­comes the lat­est vic­tim of the FDA's pan­dem­ic-re­lat­ed de­lays as it push­es off ap­pli­ca­tion for skin graft

With Covid-19 lock­ing down trav­el across the world, not even drug safe­ty reg­u­la­tors have been spared from cost­ly de­lays. For the FDA, whose in­spec­tion sched­ule keeps the trains on time for new mar­ket­ing ap­provals, those de­lays are con­tin­u­ing to prove cost­ly.

The FDA has pushed re­view of Mallinck­rodt’s al­lo­gene­ic skin graft for burns, dubbed Strat­a­Graft, af­ter the agency ad­mit­ted it wasn’t able to con­duct a plant in­spec­tion in the need­ed time­frame for a de­ci­sion, the drug­mak­er said last week.

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