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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Members unanimously endorse product and mostly supported abuse-deterrent language; several panelists suggest warning about possible harmful effects of excipients by abusing product intravenously.
FDA advisory committee members support approval of investigational hemophilia B treatment nonacog beta pegol but say Novo Nordisk needs more systematic approach to monitoring for neurological and developmental adverse events.
Nonprescription Drug and the Drug Safety and Risk Management advisory committees jointly vote 15-5 that combining antacid with aspirin, acetaminophen or other analgesic ingredients is not a combination that should be allowed under an OTC monograph.