Some US FDA Advisory Committee Meetings Likely To Remain Virtual Post-Pandemic
Peter Stein says FDA will set criteria for holding a virtual meeting and will be seeking stakeholder feedback.
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Despite acknowledging that fully in-person meetings overall are better, survey respondents said they still want the flexibility that virtual attendance offers.
Stakeholders believe virtual meetings should remain an option going forward, but that in-person sessions should still be convened in many cases.
Committee members rebuked FDA for its positive review of Biogen’s Alzheimer’s disease drug, objecting to its ‘terrifically one-sided’ analysis of data, the short shrift given the contrary conclusions of its own statistician, and its interpretation of a dosing study to support the sole positive Phase III study.