Development of new medicinal products for the treatment of ulcerative colitis

Keywords Drug evaluation, drug approval, ulcerative colitis
Description This document provides guidance for the evaluation of new medicinal products in the treatment of ulcerative colitis. It clarifies the requirements for clinical documentation needed to support a marketing authorisation, the selection of patients, the recommended methods to assess efficacy, the strategy and design of clinical trials, safety aspects and overall strategy of development.

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