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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Despite lack of enthusiasm with immunobridging study data, the panel endorsed emergency use in certain at-risk populations, in part because it would be hard to turn down the Moderna booster when an identical EUA had been issued for Pfizer/BioNTech's mRNA vaccine.
Agency assessors couldn’t independently verify several Janssen analyses of booster shot data and raised concerns about small samples sizes and an unvalidated immunogenicity assay.
The BBB National Program Inc. expects to double the number of National Advertising Division SWIFT reviews completed in 2023 compared with last year as stakeholders grow more comfortable with the process. At its annual conference in Philadelphia 19-20 September, NAD said it is speeding up the time it takes to complete both SWIFT and standard track reviews.