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FDA Advisory Committees

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Latest From Advisory Committees

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.

Advisory Committees Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

GSK Moves Closer To Priority Review Voucher As US Panel Backs Malaria Drug Tafenoquine

GlaxoSmithKline's user fee date is July 22, four days before advisory committee review of 60 Degrees’ separate application for the compound.


Advisory Committees Drug Review

GSK’s Malaria Drug Tafenoquine Heads To US FDA Panel Review With Agency Backing

Approval could bring GlaxoSmithKline a tropical disease priority review voucher.


Advisory Committees Drug Review

US FDA's Biosimilar Advisory Committee Policy Evolves

If first-in-class biosimilar doesn't raise new scientific issues, it may not need advisory committee meeting, FDA's Christl says in interview with the Pink Sheet, suggesting a case-by-case approach going forward.

Biosimilars Advisory Committees

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review
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