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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Heading into an advisory committee review, agency suggests belantamab’s risks of keratopathy and other ocular issues have not been fully characterized and questions whether the proposed mitigation measures, including dosing modifications, are adequate.
US FDA cardiovascular and renal drugs panel will weigh approvability of the vasopressin analog during a nine-hour, online meeting 15 July; terlipressin was the focus of a 2009 complete response letter but met its primary endpoint in the recent CONFIRM trial.
Announcement of the 14 July Oncologic Drugs Advisory Committee meeting follows a successful, two-day trial run of the virtual format by the oncology pediatric subcommittee that featured a mix of prerecorded and live sponsor presentations and strict adherence to a call/response approach to ensure orderly conduct.