Draft concept paper on the need for revision of the guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products and the related core summary of product characteristics

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Download document Draft concept paper on the need for revision of the guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products and the related core summary of product characteristics
Reference number EMA/CHMP/BPWP/572810/2013
Status draft: consultation open
First published 28/05/2014
Last updated 28/05/2014
Consultation start date 01/06/2014
Consultation end date 31/08/2014
Email address for submissions bpwpsecretariat@ema.europa.eu

Summary

The currently approved ‘guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products’ came into operation in January 2005. Since then, new fibrin sealant products have been authorised, new methods of application have established and applicants have sought scientific advice on the clinical development of further fibrin sealant / haemostatic products or new indications for approved fibrin sealant products. A revision of the guideline seems appropriate to reflect recent gains in clinical experience.