Embrace the Opportunities in a Changing FDA Advisory Committee Landscape

Over the past four years, we’ve seen seismic shifts in the conduct of FDA Advisory Committee (AdCom) meetings. Changes already in place and those on the horizon are creating new challenges for sponsors. The biggest challenge has been adapting to the virtual format, which then morphed into a hybrid format, and is now transitioning back to in-person meetings. In addition, sponsors have had to deal with tighter timelines for point-counterpoint briefing documents and shared Q&A with the FDA. These challenges also create opportunities for a productive and transparent dialog with clinicians and regulators.