The Advancing Standards in Regenerative Medicine Act directs the Secretary of the United States Health and Human Services Agency to establish a public-private Standards Coordinating Body in Regenerative Medicine and Advanced Therapies. The function of the body is defined as (1) identify opportunities for the development of laboratory regulatory science research and documentary standards that the Secretary determines would support the development, evaluation, and review of regenerative medicine products; and (2) work with such Standards Coordinating Body, as appropriate, in the development of standards described in paragraph (1).
The Standards Coordinating Body (SCB) includes membership of the entire cross-section of regenerative medicine stakeholders. FACT was pleased to join as a charter member, and will organize its efforts as part of a consortium of non-government stakeholders that seeks to partner with one or more government organizations and regulatory agencies to coordinate consensus standards development efforts. More specifically, the SCB seeks to enable more efficient and successful clinical and commercial development of cellular/gene and regenerative medicine therapies through coordinating and prioritizing development of national/international standards for measurement assurance (among other objectives).
As the SCB is formalized in the coming months, FACT will announce milestones and initiatives to its stakeholders.