Public consultation opens on draft guideline on clinical investigation of medicinal products for treatment of acute heart failure
The European Medicines Agency has launched a public consultation on the revised guideline on the clinical investigation of medicinal products for the treatment of acute heart failure.
The document under review is a revised version of the addendum to the Committee for Medicinal Products for Human Use (CHMP) note for guidance on the clinical investigation of medicinal products for the treatment of cardiac failure. It replaces the addendum on acute cardiac failure to this note for guidance.
The revised document is intended to provide updated guidance on the evaluation of medicines for the treatment of acute heart failure on those aspects that are not adequately covered in the guideline on chronic heart failure.
The text has been updated in relation to factors, in particular patient characteristics, that have an impact on the outcome of acute-heart-failure trials and their evaluation. The update also addresses aspects such as acceptable endpoints, early studies and cardiovascular events in elderly patients.
Comments on the guideline should be submitted by 15 April 2013.
The completed comments form should be sent to firstname.lastname@example.org