GSK's Tafenoquine Faces Questions Over Review Pathways At US FDA Panel
Advisory committee questions about malaria drug’s breakthrough therapy and orphan drug designations reflect lingering confusion about how agency’s various regulatory pathways impact product development and approval.
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GlaxoSmithKline's user fee date is July 22, four days before advisory committee review of 60 Degrees’ separate application for the compound.
Approval could bring GlaxoSmithKline a tropical disease priority review voucher.
“Preliminary clinical evidence” should demonstrate substantial improvement in effectiveness or safety over available therapies but likely will not be sufficient to support approval, final guidance explains.