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.
On September 27, 2017, FDA awarded a one-year contract to Nexight Group and the Standards Coordinating Body (SCB) to coordinate community efforts toward the development of standards for regenerative medicine therapies. Under this contract, Nexight has utilized public workshops and webinars to develop processes that will enable the identification of needed standards and facilitate the development of standards that will have a high impact on the quality and safety of regenerative medicine therapies. Also, under the contract, Nexight published “The Regenerative Medicine Standards Landscape” outlining existing standards applicable to analytical testing, bioprocessing, product quality, preclinical study standards and clinical trial standards. This document is updated annually and can be found on the SCB website.
Workshops Supporting Standards Development
- FDA-NIST-SCB Workshop: Realizing the benefits of 21st Century Cures through Standards Development, March 18-19, 2019 https://www.standardscoordinatingbody.org/march2019workshop
- NIST-FDA Genome Editing Workshop, April, 2018
- NIST-FDA Flow Cytometry Workshop: Building Measurement Assurance in Flow Cytometry, October, 2017
- NIST-FDA Cell Counting Workshop: Sharing Practices in cell counting measurements, April, 2017