FDA outlines process for recognizing standards for regenerative medicines

by Joanne S. Eglovitch – Regulatory Focus

The US Food and Drug Administration (FDA) has issued final guidance describing its process for recognizing voluntary consensus standards (VCS) to spur the development of regenerative medicine therapies (RMTs) evaluated within the agency’s Center for Biologics Evaluation and Research (CBER).

RMTs include cell therapies, therapeutic tissue engineering products, human cell and tissue products and combination products. RMTs may also include some human gene therapies, such as genetically modified cells that lead to a sustained effect on cells or tissues, and xenogeneic cell products.

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