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# FDA Facilitating Efforts to Coordinate Regenerative Medicine Therapy Standards
- URL: https://www.fdaweb.com/fda-facilitating-efforts-to-coordinate-regenerative-medicine-therapy-standards/
- Published: 2021-02-18T12:00:00.000Z
- Updated: 2026-09-14T16:47:24.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148700

FDA says that in response to a section of the 21st Century Cures Act on developing standards for regenerative medicine therapies, it is facilitating efforts to coordinate such standards development. In an online [notice](https://www.fda.gov/vaccines-blood-biologics/standards-development-regenerative-medicine-therapies?ref=fdaweb.com), the agency says it has awarded an annual contract to Nexight Group and the Standards Coordinating Body to coordinate community efforts toward the development of standards for regenerative medicine therapies.

Under the contracts, FDA says, Nexight has used public workshops and Webinars to develop processes that have enabled the identification of needed standards and facilitated the development of standards that have a high impact on the quality and safety of regenerative medicine therapies. Nexight also has published annually “The Regenerative Medicine Standards Landscape,” a report identifying needed standards, standards under development, and existing standards applicable to analytical testing, bioprocessing, product quality, preclinical study standards, and clinical trials of regenerative medicine therapies.