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EMA prepares guidance on stem cell-based medicines

This article was originally published in Scrip

Executive Summary

The European Medicines Agency has drawn up some ideas for future guidance on stem cell-containing medicines, with a focus on issues such as the ability of human embryonic stem cells to form teratomas and the need for long-term follow-up of efficacy and safety. The ideas are contained in a "reflection paper" that interested parties are invited to comment on by 30 June.

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