Mallinckrodt faces regulatory delay as COVID-19 restrictions continue to upend FDA's inspection schedule

Mallinckrodt faces regulatory delay as COVID-19 restrictions continue to upend FDA's inspection schedule

Source: 
Fierce Pharma
snippet: 

As COVID-19 continues to run rampant, the FDA has struggled to keep its manufacturing inspection schedule on track. This week, Mallinckrodt became the latest regulatory victim.

Mallinckrodt will have to wait a bit longer for an FDA decision on its regenerative skin tissue therapy StrataGraft, as COVID-19 travel restrictions forced the delay of a manufacturing plant inspection, the company said Friday. It's a similar tune to the one other drugmakers have been singing during the pandemic era, with the FDA delaying a slate of reviews last year for similar reasons.