Clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Scientific guideline

HumanScientific guidelines

Italian is available via eTranslation, the European Commission's machine translation service.

Translate to Italian | Important information about machine translation

This document provides guidance for the evaluation of new medicinal products for prevention and treatment of acute respiratory distress syndrome.

Keywords: Acute respiratory distress syndrome (ARDS), biomarker, phenotype, pandemic preparedness

Current version

Guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2

Adopted Reference Number: EMA/58320/2025 rev. 2 Legal effective date:

English (EN) (482.37 KB - PDF)

Pubblicato per la prima volta:
Visualizza

Document history - Revision 2

Guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2

Adopted Reference Number: EMA/58320/2025 rev. 2 Legal effective date:

English (EN) (482.37 KB - PDF)

Pubblicato per la prima volta:
Visualizza

Draft guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2

Draft: consultation closed Consultation dates: to Reference Number: EMA/67201/2025 Summary:

This guideline replaces the guideline on clinical investigation of medicinal products for the treatment of patients with acute respiratory distress syndrome (EMEA/CPMP/EWP/504/97 Rev.1).

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

English (EN) (453.45 KB - PDF)

Pubblicato per la prima volta:
Visualizza

Concept paper on revision of the Guideline on clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome

Draft: consultation closed Consultation dates: to Reference Number: EMA/CHMP/175067/2023

English (EN) (281.3 KB - PDF)

Pubblicato per la prima volta:
Visualizza

Document history - Revision 1

Guideline on clinical investigation of medicinal products in the treatment of patients with Acute Respiratory Distress Syndrome - Revision 1

Adopted Reference Number: EMEA/CPMP/EWP/504/97 Rev 1 Legal effective date:

English (EN) (93.2 KB - PDF)

Pubblicato per la prima volta: Ultimo aggiornamento:
Visualizza

Overview of comments received on draft guideline on clinical investigation of medicinal products in prevention and treatment of Acute Respiratory Distress Syndrome

Reference Number: CHMP/EWP/358390/2006

English (EN) (65.08 KB - PDF)

Pubblicato per la prima volta: Ultimo aggiornamento:
Visualizza

Share this page