Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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FDA Schedules Vaccines Panel On COVID Boosters As Questions Linger About Data Adequacy
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.
Gene Therapies: US Panel To Weigh Strategies For Preventing, Mitigating AAV Vector Toxicities
FDA seeks advice on screening patients potentially at higher risk for liver and other injuries, strategies to implement before or after gene therapy administration to head off or mitigate potential adverse events, and whether upper limits should be set for the total vector genome dose and total capsid dose.
Gene Therapy AAV Vector Toxicities Get US FDA's Attention
Advisory committee will discuss five types of toxicity risks with adeno-associated virus vector-based gene therapy products at a two-day meeting in September, which follows some recent high-profile instances of adverse events that have delayed development programs.