Guideline on Clinical Investigation of Medicinal Products for the Treatment of Gout (Draft)

EMA updated this Draft with the end of consultation on August 31, 2019

The main aim of the guideline is to address general guidance on the development of medicinal products for the treatment of gout. In this document, guidance is provided on the clinical development of new urate-lowering therapy (ULT) and anti-inflammatory treatment options. The study design, inclusion criteria, primary endpoints and trial duration largely depend on the treatment goal and mode of action of the new drug.

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