Ferring’s Fecal Transplant Gets Through AdComm, Aided By Preference For Standardized Product
US FDA's Vaccines and Related Biological Products Advisory Committee endorses Rebyota for recurrent C. difficile infection; most panelists prefer a product whose manufacturing will be regulated, even one with lingering concerns about efficacy or safety, over the current landscape.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
A 2013 FDA decision to allow certain fecal microbiota transplants for C. difficile infection without an investigational new drug application hurt Rebiotix’s Phase III trial enrollment and may ultimately leave it without strong enough data for advisory committee endorsement or FDA approval.
First OIG report on FDA’s accelerated approval program as part of Aduhelm-spurred review doesn’t break new ground but will likely bring new wave of focus on the costs incurred to the government when drug companies fail to complete confirmatory trials in a timely manner just as reform advocates are hoping to muster enough attention on the topic to get legislative change this year.