US FDA May Make Pre-Recorded Virtual Adcom Presentations Available Before Meeting
The move is intended to streamline virtual advisory committee meetings, FDA official says.
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GSK’s Trelegy Ellipta: US FDA Panel To Weigh Role Of Inhaled Corticosteroids On Mortality Results
GSK wants labeling to reflect all-cause mortality results from the 10,355-patient IMPACT trial of the triple-combination therapy for COPD, but FDA questions whether the survival benefit was driven by the abrupt halt in inhaled corticosteroid treatment for some randomized subjects.
Virtual Adcom Vet Says In-Person Events May Be Better For Product Approval Recommendations
Syndax CEO also says US FDA’s virtual meetings would benefit from having advisory committee members on camera, which may be a technology challenge.
Mallinckrodt’s Hepatorenal Syndrome Drug Terlipressin Gets A Virtual AdComm
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.