Description

The scope of this risk based interim policy regarding the Clinical Trial requirements is limited to classical FMT (fresh or frozen) used in the treatment of patients with CDI not responsive to conventional therapies and it is subject to the conditions listed in Section 2.

Resources

Name	Format	Description	Link
Guidance Document: Fecal Microbiota Therapy Used in the Treatment of Clostridium difficile Infection Not Responsive to Conventional Therapies	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/regulation-fecal-microbiota-therapy-treatment-difficile-infections.html#s1.3
Guidance Document: Fecal Microbiota Therapy Used in the Treatment of Clostridium difficile Infection Not Responsive to Conventional Therapies	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/produits-biologiques-radiopharmaceutiques-therapies-genetiques/information-demandes-presentations/lignes-directrices/bacteriotherapie-fecale-traitement-infection-difficile-traitements-classiques.html#s1.3

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