FDA’s Fecal Transplant Enforcement Discretion May Jeopardize Rebiotix’s Approval Prospects

 
• By Sarah Karlin-Smith

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.

person clutching stomach
Rebiotix’s fecal microbiota transplant looks to face uphill fight at FDA advisory committee 22 September • Source: Shutterstock

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