Faecal microbiota transplantation: A sui generis biological drug, not a tissue

Author:

Megerlin F.,Fouassier E.,Lopert R.,Bourlioux P.

Publisher

Elsevier BV

Subject

Pharmaceutical Science,Pharmacology

Reference22 articles.

1. Duodenal infusion of donor feces for recurrent C. difficile;Van Nood;N Engl J Med,2013

2. Le transfert de flore digestive : une revue de la littérature;Barbut;Ann Pharm Fr,2014

3. Policy: how to regulate faecal transplants;Smith;Nature,2014

4. FDA. Guidance for industry – Enforcement policy regarding investigational new drug requirements for use of fecal microbiota for transplantation to treat C. difficile infection not responsive to standard therapies (February 2014 Guidance for consultation). Center for Biologics Evaluation and Research, FDA doc. 79 FR 10814.

5. NICE. Interventional procedure overview of faecal microbiota transplant for recurrent Clostridium difficile infection IP 1096 [IPG 485] (2013).

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