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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Lack of reference standards inhibits ability to make comparisons between products or set caps for total vector genome dose or total capsid dose, advisory committee says; panelists suggest other approaches to prevent and mitigate toxicities, including running longer-term animal studies and investigating the efficacy of immunosuppression prophylaxis and treatment strategies.
VRBPAC could help restore some confidence in any booster decision after White House moved ahead of FDA and CDC, but without hard outcomes data and no proven immune correlate of protection, support for Pfizer’s sBLA at the 17 September advisory committee meeting seems far from guaranteed.
On this week’s podcast: One of the more interesting and important trends in medtech in recent years is the emergence of robotic assisted surgery. But as RAS procedures increase, so do the chances of something going wrong. And when it does, who’s to blame? The robot or the surgeon?