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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Opioid-Sparing Regimens Face High Hurdles After US FDA Advisory Cmte.
Panelists felt the phrase "opioid sparing" was too broad, and contended that it is difficult to develop a non-opioid alternative without an opioid as an active comparator.
Mallinckrodt's Abuse Deterrent Oxycodone IR Narrowly Wins US FDA Panel Backing
"Incremental" step forward is sufficient for product to be labeled as deterring abuse by nasal, but not intravenous route, advisory committee members conclude.
EU Crunch Time For Mirikizumab, New Covid-19 Vaccine & Other Drugs
The European Medicines Agency’s human medicines committee, the CHMP, is this week deciding whether to back marketing approval for eight new drugs and a coronavirus vaccine.