Meeting Reporting Requirements
The U.S. Food and Drug Administration (FDA) considers stool for investigational FMT an investigational drug, a classification that carries certain reporting requirements. We aggregate and share your submissions to our material tracking program with the FDA. Adherence to OpenBiome’s follow-up reporting protocol is required for continued access to investigational FMT preparations.
Follow-Up Reporting Instructions
Below, we have shared a follow-up reporting checklist for investigational FMT preparations manufactured by the University of Minnesota (UMN) and distributed by OpenBiome as well as instructions for reporting an Adverse Event.
Reporting Checklist for Investigational FMT Preparations Manufactured by the University of Minnesota (UMN)
Reporting an Adverse Event
If you suspect that one of your patients has experienced an adverse event that could be related to an investigational FMT preparation distributed by OpenBiome, please fill out and submit OpenBiome's online Adverse Event Reporting Form within 24 hours to alert our Clinical Safety Team.
Please review the checklist on the fourth page of our Adverse Event Reporting Guide to ensure that you have the necessary information ready to complete your report. Once submitted, an OpenBiome medical professional will contact you to discuss the specifics of your case and advise whether additional reporting requirements to the FDA may be needed.
Thank you for enabling OpenBiome’s mission of serving patients, as well as proactively monitoring the efficacy of investigational FMT treatments manufactured by the University of Minnesota and distributed by OpenBiome on a network-wide and per-donor basis.
The safety and efficacy data you provide will be used to optimize treatment for patients and inform the design of future microbiome-based therapies.
The National FMT Registry:
The Largest Planned FMT Study
OpenBiome strongly encourages enrollment in the AGA’s FMT National Registry. The registry tracks and collects FMT procedure data and is a critical resource for understanding short and long-term safety and efficacy. Participation in the registry may be done in place of our standard clinical outcome reporting requirements.
Initial results of the first 259 participants enrolled at 20 sites have been published on Gastroenterology
AGA aims to track
FMT recipients over 10 years.