Clinical development of medicinal products for the treatment of cystic fibrosis - Scientific guideline
HumanScientific guidelines
This document provides guidance on the clinical development and evaluation of medicinal products for the treatment of cystic fibrosis.
Keywords: Antibiotics, cystic fibrosis, exocrine pancreas insufficiency, paediatrics, pancreatic enzymes preparations (PEP), pulmonary disease, pulmonary infection, pseudomonas aeruginosa
Current effective version
Guideline on the clinical development of medicinal products for the treatment of cystic fibrosis - First version
AdoptedReference Number: EMEA/CHMP/EWP/9147/2008Legal effective date:
English (EN) (278.37 KB - PDF)
First published: Last updated:
Document history
Concept paper on the need for revision of the guideline on the clinical development of medicinal products for the treatment of cystic fibrosis (CHMP/EWP/9147/2008) - Revision 1
Draft: consultation closedConsultation dates:
to Reference Number: EMA/CHMP/259918/2016Summary:
The proposed guideline will replace 'guideline on the clinical development of medicinal products for the treatment of cystic fibrosis EMEA/CHMP/EWP/9147/2008 corr.
English (EN) (98.22 KB - PDF)
First published: Last updated:
Guideline on the clinical development of medicinal products for the treatment of cystic fibrosis - First version
AdoptedReference Number: EMEA/CHMP/EWP/9147/2008Legal effective date:
English (EN) (278.37 KB - PDF)
First published: Last updated:
Draft guideline on the clinical development of medicinal products for the treatment of cystic fibrosis - First version
Draft: consultation closedReference Number: EMEA/CHMP/EWP/9147/2008
English (EN) (166.13 KB - PDF)
First published: Last updated:
Concept paper on the need for a guideline on the development of new medicinal products intended for the management and treatment of cystic fibrosis - First version
Reference Number: EMEA/CHMP/EWP/81927/2007
English (EN) (97.61 KB - PDF)
First published: Last updated:
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