Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Uncertainties about clinical benefit and neurodevelopmental safety drive lopsided recommendation against approval; some advisory committee members say that even FDA’s REMS proposal wouldn't be enough to allow stannsoporfin to come to market without further studies.
Plazomicin's BSI Indication Gets 'No' From Advisory Panel, But US FDA Still Might Approve Under LPAD Pathway
Achaogen should at least be reassured by advisory committee's unanimous 'yes' vote for plazomicin's cUTI indication.
Antiviral wins unanimous endorsement on strength of efficacy data in two animal models and absence of major safety concerns in humans. FDA's advisors also see potential utility in other orthopoxviruses, particularly naturally occurring monkeypox outbreaks in Africa.