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  4. Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies - 11/04/2019 - 11/04/2019
  1. FDA Meetings, Conferences and Workshops

Public Hearing

Event Title
Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies
November 4, 2019

Scheduled
Date:
November 4, 2019
Time:
9:00 AM - 4:00 PM ET

The Food and Drug Administration is convening a public hearing entitled, “Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies.”

Purpose

The purpose of the public hearing is to obtain public input on the state of the science regarding FMT to treat C. difficile infection not responsive to standard therapies, including the available clinical evidence for safety and effectiveness of FMT for this use and to better understand the impact of FDA’s enforcement policy on product development. Please see Federal Register Notice for more information: https://www.federalregister.gov/d/2019-19643.

Video Recordings

Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies - Video Part 1

Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies - Video Part 2

Location

Food and Drug Administration
White Oak Campus
10903 New Hampshire Avenue
Building 31, The Great Room
Silver Spring, MD 20993

Entrance for public workshop participants is through Building 1, where a routine security check will be performed. For more information on parking and security procedures on the White Oak campus, please refer to:
https://www.fda.gov/about-fda/white-oak-campus-information/public-meetings-fda-white-oak-campus.

Registration

Persons seeking to present or speak at the public hearing must register by October 8, 2019. Persons seeking to attend but not present at the public hearing must register by October 22, 2019. Registration for the live webcast will be open until the day of the hearing (November 4, 2019). Please register here: https://www.eventbrite.com/e/use-of-fecal-microbiota-for-transplantation-to-treat-clostridium-difficile-infection-not-responsive-tickets-63906239282.

There is no onsite registration for this hearing. Early registration is recommended because seating is limited. FDA will notify registered speakers of their scheduled times and make an agenda available on its website on or before October 25, 2019.

Contact Information

Sherri Revell or Loni Warren Henderson
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
240-402-8010
[email protected]

Contact

Event Contact
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
(800) 835-4709
[email protected]
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