RMAT Designation…What Is It And Is It Right For Your Therapeutic Product?

Since the 21st Century Cures Act was passed in December 2016, the US FDA has instated a framework for the regulation of regenerative medicine products and has plans to support and expedite the development of regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (HCT/Ps). The Agency has published several guidance documents specific to the complex issues of these types of products, with the February 2019 Guidance for Industry: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions providing the Agency’s recommendations on the expedited development and review of regenerative medicine therapies. A drug is eligible for regenerative medicine advanced therapy (RMAT) designation if: