EMA: Draft guideline on clinical investigation of medicinal products for the treatment of acute heart failure

The CHMP Note for Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Cardiac Failure (CHMP/EWP/235/95, rev. 1) provides limited regulatory guidance for development of medicinal product for the treatment of acute heart failure and led to the addendum on acute heart failure (CHMP/EWP/2986/03). The current document is a revised version of this addendum and is intended to provide updated guidance on the evaluation of drugs in the treatment of Acute Heart Failure (AHF) on those aspects that are not adequately covered in the guideline on chronic heart failure.