Delayed Advisory Committees Need Not Worry Sponsors Too Much
US FDA advisory committee meetings held in close proximity to user fee goal dates are approved at a similar rate to all products reviewed by the advisory panels, according to a Pink Sheet analysis of drug and biologic advisory committees since 2015.
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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.
US FDA says it is preparing to hold ‘virtual’ advisory committee meetings amid the COVID-19 outbreak. Does anyone want to go first?