FDA Resource Page for Regenerative Medicine Standards Development Highlights SCB

Washington, DC (June 13, 2019) — FDA recently published an online resource page summarizing its efforts to coordinate the development of regenerative medicine standards, in support of Section 3036 of the 21st Century Cures Act (December 2016). In particular, this resource page highlights the FDA-funded work that SCB and Nexight Group have undertaken to support FDA efforts, including two significant accomplishments:

• The Regenerative Medicine Standards Landscape report, which outlines existing standards applicable to analytical testing, bioprocessing, product quality, logistics, preclinical studies, and clinical trials. This report is updated annually and freely available on the SCB web site.

• The Realizing the Benefit of 21st Century Cures through Standards Development workshop, organized by SCB and Nexight Group in March 2019. The workshop—made possible through support from FDA and NIST—focused on the benefits of standards and of participating in the standards development process. Participants also had the opportunity to learn about current regenerative medicine standards efforts that need community support and participate in discussions to support their advancement. Materials from the workshop can be accessed through the SCB web site.

“We’re so pleased to be working with FDA to help advance standards development in regenerative medicine,” noted SCB’s Executive Director, Peter Reczek, PhD. “This resource page will allow our work to reach a broader audience and encourage increased involvement from the community.”

Information from three additional NIST-FDA workshops is also available through this resource page.

For more information on getting involved in the work that SCB is undertaking to support FDA in the development of regenerative medicine standards, please contact SCB.