Guidance Document: Fecal Microbiota Therapy Used in the Treatment of Clostridium difficile Infection Not Responsive to Conventional Therapies (English, HTML)

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Publisher-reported update

2022-06-07

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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