Clinical evaluation of antifungal agents for the treatment and prophylaxis invasive fungal disease - Scientific guideline

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This document addresses the clinical development of antifungal agents for the treatment and prophylaxis of invasive fungal disease.

Keywords: Invasive fungal disease (IFD), rapid diagnostic tests, combination regimens, salvage therapy, patients with febrile neutropenia, fungaemia

Current effective version (under revision, see document history)

Guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease

Adopted Reference Number: CHMP/EWP/1343/01 Rev. 1 Legal effective date:

English (EN) (190.98 KB - PDF)

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Document history - Revision 2

Concept paper on the revision of the guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease

Draft: consultation open Consultation dates: to Reference Number: EMA/133954/2026 Summary:

The proposed guideline will replace guideline on the clinical evaluation of antifungal agents intended for the treatment and prophylaxis of invasive fungal diseases (CHMP/EWP/1343/01 Rev. 1).

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

English (EN) (192.76 KB - PDF)

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Document history - Revision 1

Guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease

Adopted Reference Number: CHMP/EWP/1343/01 Rev. 1 Legal effective date:

English (EN) (190.98 KB - PDF)

Publicado por primera vez: Última actualización:
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Overview of comments received on ' Guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease' (CHMP/EWP/1343/01 Rev.1)

Reference Number: EMA/186797/2010

English (EN) (122.74 KB - PDF)

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Draft guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease

Draft: consultation closed Reference Number: CHMP/EWP/1343/01 Rev. 1

English (EN) (110.94 KB - PDF)

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Document history - First version

Points to consider on the clinical evaluation of new agents for invasive fungal infections

Adopted Reference Number: CPMP/EWP/1343/01 Legal effective date:

English (EN) (265.75 KB - PDF)

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