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Federal Register Notice Public Workshop: Fecal Microbiota for Transplantation - Presentations May 2, 2013 Transcript(PDF - 338KB) May 3, 2013 Transcript(PDF - 359KB) Important Information about IND Requirements for Use of Fecal Microbiota to Treat Clostridium difficile Infection Not Responsive to Standard Therapies[ARCHIVED]
Public Workshop: Fecal Microbiota for Transplantation
Date and Time:
May 2 - 3, 2013, from 8:30 a.m. to 5 p.m.
Lister Hill Center Auditorium
National Institutes of Health, Bldg. 38A
8600 Rockville Pike, Bethesda, MD 20894
Workshop Goals and Objectives:
Fecal microbiota samples that have been isolated from healthy individuals are being investigated for use in the treatment of Clostridium difficile colitis. Published data from case studies and metaanalyses suggest that the use of fecal microbiota to restore gut flora may be an effective therapy in the management of refractory C. difficile infection. However, the efficacy of this intervention has not yet been demonstrated in controlled clinical trials. Such controlled trials are needed to demonstrate the safety and effectiveness of FMT products for C. difficile infection refractory to conventional therapy. FMT is also being considered as a treatment for inflammatory bowel disease, obesity, and other disorders, and controlled trials are needed in these settings as well.
Clinical studies to evaluate the safety and efficacy of FMT are regulated by FDA. FDA's primary objectives in reviewing an investigational new drug application are, in all phases of the investigation, to assure the safety and rights of subjects, and, in Phases 2 and 3, to help insure that the quality of the scientific evaluation of the product is adequate to permit an evaluation of safety and effectiveness. In addition, the complex nature of FMT products presents specific scientific and regulatory challenges.
To facilitate clinical development of FMT, CBER and NIAID are holding this workshop to provide a forum for the exchange of information, knowledge, and experience between CBER, NIAID, and the scientific-medical community.
Mail or fax your registration information (including name, title, firm name, address, telephone, and fax numbers) to Chris Nguyen (see Contact Person) or email to CBERPublicEvents@fda.hhs.gov (subject line: FMT Workshop Registration) by April 18, 2013.
There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 8 a.m.
Preregistered participants will receive additional information on security procedures, parking, and public transportation with their email registration confirmation.
If you need special accommodations due to a disability, please contact Chris Nguyen (see Contact Person) at least 7 days in advance.
Center for Biologics Evaluation and Research (HFM-49)
Food and Drug Administration
1401 Rockville Pike, suite 200N
Rockville, MD 20852-1448
email: CBERPublicEvents@fda.hhs.gov (subject line: FMT Workshop)