About FDA
Fecal Microbiome Transplantation Workshop
Description: The purpose of the workshop is to exchange information with the medical and scientific community on the regulatory and scientific challenges of fecal microbiome transplantation.
Public Health Outcome: The workshop will encourage the identification of issues and exchange of ideas associated with Fecal Microbiome Transplantation (FMT). FMT products are being evaluated by the medical community for treatment of Clostridium difficile colitis, a disease that is unresponsive to antibiotics.
Accomplishment: Public Transcripts and an FDA-developed overview presentation have been posted to the FDA Website: Public Workshop: Fecal Microbiota for Transplantation
During the two day workshop, FDA scientists and experts from academia, government (NIH and CDC), industry and the public exchanged scientific and regulatory information concerning fecal microbiota transplantation (FMT). FMT research needs were discussed. FDA received suggestions and comments concerning the future development and regulation of FMT products.
OVRR achieved the goals of the workshop. FDA will continue to develop regulatory pathways and strategies to insure the safe and effective use of FMT products.
Briefing Status: COMPLETED
Prior Briefing Status: ON TRACK
Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
---|---|---|---|
A. Form workshop planning committee and appoint chairperson |
6/30/2012 |
Completed | 6/30/2012 |
B. Publish Federal Register Notice |
2/25/2013 |
Completed | 2/25/2013 |
C. Complete Workshop Planning |
3/22/2013 |
Completed | 3/4/2013 |
D. Conduct Workshop |
5/2-5/3/2013 |
Completed | 5/2-5/3/2013 |
E. Complete Workshop Summary |
6/28/2013 |
Completed | 6/17/2013 |
Key Projects Legend
Milestone Status | Definition |
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Not Yet Started | Work for specific milestone has not yet been started. |
Completed | Milestone and/or overall project is completed. |
On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |