Guidance Document: Fecal Microbiota Therapy Used in the Treatment of Clostridium difficile Infection Not Responsive to Conventional Therapies

Guidance Document: Fecal Microbiota Therapy Used in the Treatment of Clostridium difficile Infection Not Responsive to Conventional Therapies 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. 2022-06-07 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyclinical-trial requirementsclassical FMTfecal microbiota therapytreatment of clostridium-difficile-Infectionnot-responsive to conventional-therapies Guidance Document: Fecal Microbiota Therapy Used in the Treatment of Clostridium difficile Infection Not Responsive to Conventional TherapiesHTML 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 TherapiesHTML 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

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.

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