Drug Regulatos Publish Draft Reflection Paper on In-vitro Cultured Chondrocyte Containing Products for Cartilage Repair
Drug Regulators, EMEA, Publish Draft Reflection Paper on In-vitro Cultured Chondrocyte Containing Products for Cartilage Repair
This reflection paper addresses specific points related to products containing autologous chondrocytes intended for the repair of lesion of cartilage of the knee not discussed in the ‘Guideline on human cell based medicinal products’ (EMEA/CHMP/410869/2006) and therefore it should be read in conjunction with the guideline. – Deadline for comments is 31st December 2009.
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Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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