One Prediction For US FDA Under Biden: More Advisory Committees
The US FDA was extraordinarily selective in its use of advisory committees for new drug applications in 2020. It is safe to bet that trend will change under President Elect Biden’s team.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Successful EMERGE trial does not provide substantial evidence of efficacy in Alzheimer’s because it cannot be divorced from its unsuccessful sister study, advisory committee says; panel’s unequivocal rejection leaves agency’s Office of Neuroscience in a tight spot given its strong support for the drug and the help it gave Biogen to get this far.