EMA Updates Guideline on Clinical Investigations of VTE Products

The European Medicines Agency (EMA) has updated its draft guideline on clinical investigations of venous thromboembolism (VTE) products, adding new definitions for bleeding events and secondary endpoints to consider for clinical trials. Secondary endpoints could relate to the reporting of surgical blood loss, blood transfusions, wound complications, functional outcomes and hepatic and cardiovascular events, the revised guideline states.
International Pharmaceutical Regulatory Monitor