Framework for the regulation of regenerative medicine products


21 May 2019 - The U.S. FDA has published four final guidance documents that are part of a comprehensive policy framework to address how the agency plans to support and expedite the development of regenerative medicine products, including human cells, tissues, and cellular and tissue-based products. 

These guidance documents build upon FDA’s risk-based, flexible regulatory framework, and underscore the agency’s commitment to help bring new and innovative treatment options to patients.

Read FDA framework

Michael Wonder

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Michael Wonder