US FDA, Sponsors Eye Best Practices For Virtual AdComms
Agency has created a centralized team to help review divisions with virtual advisory committee preparations and is trying to notify sponsors earlier in the review process about the need for a panel; sponsors cite importance of having a back channel of communications so team members can communicate with each other while an AdComm is underway.
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Peter Stein says FDA will set criteria for holding a virtual meeting and will be seeking stakeholder feedback.
Stakeholders believe virtual meetings should remain an option going forward, but that in-person sessions should still be convened in many cases.
One of the lessons learned from the pandemic may be that virtual meetings can be used in place of an in-person session more often.