Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to address indication-specific clinical data requirements

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/351889/2013
Published04/07/2012
Effective from01/05/2014
KeywordsNon-inferiority study designs, superiority study designs, rare and multidrug-resistant organisms, pathogen-specific indications
DescriptionThis document is an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. It provides additional guidance on studies and clinical development programmes intended to support specific indications for use.


Document history

First version

Current version

Adopted guideline

 

Draft guideline

 

Concept paper

In operation: 01/05/2014–present

 

Published: 04/07/2012

 

Published: 06/10/2011

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