Concept Paper on Revision of the Guideline on Clinical Investigation of Medicinal Products in the Treatment of Patients with Acute Respiratory Distress Syndrome (ARDS)

4 May 2023 – the EMA proposed guideline will replace the Guideline on clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome. Submit comments by 31 July 2023.

This concept paper concerns the guideline that is intended to provide guidance for the evaluation of new medicinal products for prevention and treatment of ARDS. The guideline came into effect in April 2007. There are several new agents in development for the treatment of ARDS. In recent requests for CHMP scientific advice on the development of new agents intended for the treatment of ARDS, several issues have emerged as being central to development programs.

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