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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Nearly every panelist cited lack of substantial evidence of efficacy in voting against approval of ALKS 5461, a fixed-dose combination of buprenorphine and samidorphan.
US FDA is recommending a REMS requiring continuous monitoring during the 60-hour infusion and no home use, a potential problem for commercial marketing.
The president’s executive order aims to give smaller companies a leg up over foreign competitors, among other objectives.