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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GSK’s Trelegy Ellipta: US FDA Panel To Weigh Role Of Inhaled Corticosteroids On Mortality Results
GSK wants labeling to reflect all-cause mortality results from the 10,355-patient IMPACT trial of the triple-combination therapy for COPD, but FDA questions whether the survival benefit was driven by the abrupt halt in inhaled corticosteroid treatment for some randomized subjects.
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.
Virtual Advisory Committees: Who Will Be First In Line To Test On-Line Meetings?
US FDA says it is preparing to hold ‘virtual’ advisory committee meetings amid the COVID-19 outbreak. Does anyone want to go first?