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FDA Advisory Committees

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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

Sanofi Gets A Helping Hand From US FDA At Dengvaxia Review

After split verdicts on efficacy and safety for Sanofi’s proposed population for the dengue vaccine, FDA added two new questions limited to pediatric use, which drew strong advisory committee support.

Advisory Committees Vaccines

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

Sanofi’s Dengvaxia: US FDA Panel Finds Pediatric Use More Acceptable Than Broader Target Population

Even a more limited label for the dengue vaccine may not be enough to overcome the lack of a readily available and reliable point-of-care diagnostic for screening potential vaccine recipients for previous dengue infection.

Advisory Committees Vaccines

Sanofi's Dengvaxia Postmarket Monitoring Plan Targets Vaccine's Safety Concerns

Company proposes enhanced real-world monitoring to identify dengue vaccine’s risks, including severe and hospitalized dengue in individuals not previously infected, US FDA says in briefing document for March 7 advisory committee meeting.

Advisory Committees Vaccines

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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