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U.S. Department of Health and Human Services

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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 DescriptionMilestone DateMilestone StatusMilestone 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 StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.


Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.