Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacterium Tuberculosis - Scientific guideline
Table of contents
This document is an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. It covers the evaluation of agents for the treatment of disease due to Mycobacterium tuberculosis.
Keywords: Mycobacterium tuberculosis, pulmonary and extrapulmonary tuberculosis, combination regimens, multidrug resistant M. tuberculosis, early bactericidal activity (EBA), sputum culture conversion (SCC)
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Draft addendum to the 'guideline on the evaluation of medicinal products indicated for treatment of bacterial infections' to address the clinical development of new agents to treat disease due to Mycobacterium tuberculos... (PDF/198.17 KB)
Draft: consultation closed
First published: 01/08/2016
Last updated: 01/08/2016
Consultation dates: 01/08/2016 to 31/01/2017
EMA/CHMP/EWP/14377/2008 Rev 1 -
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Concept paper on revision of the addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to tre... (PDF/85.8 KB)
Draft: consultation closed
First published: 28/11/2014
Last updated: 28/11/2014
Consultation dates: 30/11/2014 to 28/02/2015
EMA/CHMP/644851/2014 -
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Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to mycobacterium t... (PDF/100.15 KB)
Adopted
First published: 29/01/2010
Last updated: 29/01/2010
Legal effective date: 01/08/2010
EMA/CHMP/EWP/14377/2008 -
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Draft addendum to the note for guidance on evaluation of medicinal products Indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacte... (PDF/90.25 KB)
Draft: consultation closed
First published: 24/04/2008
Last updated: 24/04/2008
EMEA/CHMP/EWP/14377/2008 -
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Concept paper on preparation of an addendum to the guideline on development of antibacterial agents to specifically address the clinical development of new agents to treat tuberculosis (PDF/92.1 KB)
First published: 26/04/2007
Last updated: 26/04/2007
EMEA/CHMP/EWP/122355/2007