EMA: Draft concept paper on the need for revision of the guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products

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.