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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Seventeen of the panelists voted that the clinical data support approval for some of Braeburns proposed doses, but no one supported the highest proposed monthly dose.
Advisory committee votes 18 to 1 for approval of the opioid abuse disorder treatment with restricted distribution; members advise post-market studies, registry.
The Bone, Reproductive and Urologic Drugs Advisory Committee will consider endpoints, clinical trial designs and other issues related to development in the disease.