Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to address indication-specific clinical data requirements - 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 provides additional guidance on studies and clinical development programmes intended to support specific indications for use.
Keywords: Non-inferiority study designs, superiority study designs, rare and multidrug-resistant organisms, pathogen-specific indications
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Draft addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) to address indication-specific clinical data (PDF/254.77 KB)
Draft: consultation closed
First published: 04/07/2012
Last updated: 04/07/2012
Consultation dates: 04/07/2012 to 31/01/2013
EMA/CHMP/776609/2011 -
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Concept paper on an addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) to address indication-specific clinical data requirements (PDF/140.04 KB)
Draft: consultation closed
First published: 06/10/2011
Last updated: 06/10/2011
Consultation dates: 22/09/2011 to 31/12/2011
EMA/CHMP/EWP/736904/2011