Concept paper on the need for revision of the note for guidance on the clinical investigation of medicinal products for the treatment of cardiac failure

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Download document Concept paper on the need for revision of the note for guidance on the clinical investigation of medicinal products for the treatment of cardiac failure
Reference number EMA/CHMP/87576/2013
Status draft: consultation closed
First published 01/03/2013
Last updated 01/03/2013

Summary

Chronic heart failure encompasses heterogeneous groups of patients with a wide spectrum of symptoms and different causes. The Committee for Medicinal Products for Human Use guideline on the clinical investigation of medicinal products for the treatment of cardiac failure addresses the development issues in this specific patient population. Recently, it became apparent that the scope of the guideline should be widened to include patients who are encountered in clinical practice and not previously addressed and to elaborate on the endpoints to be studied.