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

This document is the revised version of the ‘Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders (CHMP/EWP/3020/03)’. It is intended to provide guidance for the evaluation of drugs 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.