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EMA: Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease

06.06.2013
Since the publication of the EMA Guidance on clinical investigation of medicinal products for the treatment of venous thromboembolic disease (CPMP/EWP/563/98) in 2000, there has been an intense research in this field. An update of the mentioned guideline is considered necessary to adapt its content to current scientific knowledge and to harmonise it with the content of new or revised EMA guidelines related to clinical investigation with antithrombotics.