Section 3036 of the 21st Century Cures Act refers to the development of standards for regenerative medicine therapies, including products designated regenerative medicine advanced therapies. In consultation with the National Institute of Standards and Technology (NIST) and stakeholders, FDA is facilitating efforts to coordinate the development of standards for regenerative medicine therapies.
Beginning in 2017, FDA has awarded an annual contract to Nexight Group and the Standards Coordinating Body (SCB) to coordinate community efforts toward the development of standards for regenerative medicine therapies. Under these contracts, Nexight has utilized 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. In addition, Nexight 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. This document is updated annually and can be found on the SCB website.
For information on the use of standards in regulatory submissions to the Center for Biologics and Evaluation (CBER) see FDA Guidance for Industry: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research.