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

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberCHMP/EWP/14377/2008
Published29/01/2010
Effective from01/08/2010
KeywordsMycobacterium tuberculosis, tuberculosis, combination regimens, multi-drug resistant tuberculosis (MDR-TB), extensively drug- resistant tuberculosis (XDR-TB), early bactericidal activity (EBA), sputum culture conversion (SCC), biomarkers
DescriptionThis 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.


Document history

Revision 1

In progress

Draft guideline

 

 

Concept paper

Published: 01/08/2016
Deadline for comments: 31/01/2017

 

Published: 28/11/2014

First version

Current version

Adopted guideline


Draft guideline


Concept paper

In operation: 01/08/2010–present


Published: 24/04/2008


Published: 26/04/2007


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