Virtual Advisory Committees Are Coming: US FDA Panels Will Be Smaller, More Focused
Planning for virtual advisory committees is underway; any applications with upcoming PDUFA deadlines with meetings still on the calendar are prime candidates, OND Director Peter Stein says.
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‘We’re coming back,’ Oncology Center of Excellence Director Richard Pazdur says. Office of New Drugs Director Peter Stein says transition from virtual to in person will be gradual because FDA is trying to be sensitive to adcomm members' need to schedule travel and demands on their time.
The move is intended to streamline virtual advisory committee meetings, FDA official says.
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.