OpenBiome Webinar: New FDA Guidance Governing FMT

In December, OpenBiome held a live webinar to discuss a new FDA guidance governing the use of fecal microbiota transplantation (FMT) and the first FDA approval of a microbiome-based therapeutic for recurrent C. difficile (rCDI). OpenBiome, along with the University of Minnesota (UMN) Microbiota Therapeutics Program, will continue operating normally and remains committed to providing safe and continued access to investigational FMT for C. difficile patients.  

It was great to see so many of our partners and patients in attendance, and discuss some of the exciting developments in the world of FMT. Here you will find an overview of the key takeaways from the webinar and a recording. 

Key Takeaways 

1. The U.S. FDA recently announced final guidance for the use of FMT in the treatment of recurrent rCDI not responsive to standard therapies. 
2. The U.S. FDA approved the first fecal microbiota product for the treatment of rCDI in adults, marking a major milestone for the field and a huge win for patients. 
3. OpenBiome confirmed it will continue distributing investigational FMT for patients suffering from rCDI not responsive to standard therapies.  

Contact: Email media@openbiome.org   

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