EMA: Draft guideline on clinical investigation of medicinal products in the treatment of lipid disorders

This document is the revised version of the existing guidance note (CHMP/EWP/3020/03) on lipid-modifying agents. The guideline is intended to provide guidance for the evaluation of medicines in the treatment of lipid disorders and details the main regulatory requirements that are expected to be followed in the development of a lipid-modifying medicinal product.