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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Survival benefit seen in GlaxoSmithKline’s IMPACT study may be due to negative effects of abrupt withdrawal of inhaled corticosteroids for some patients instead of benefits of the triple-combination therapy itself, advisory committee members said.
The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.
Five years after an advisory committee meeting was cancelled, panel will consider whether required postmarketing studies show Purdue’s reformulated opioid ‘meaningfully’ reduces abuse and overdose.