Complete response letters are becoming a more likely outcome for applications with the FDA’s marquee expedited review status, an analysis using the Pink Sheet’s US FDA Performance Tracker shows.
When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval
More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.
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South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.