FDA Publishes Guidance on Regenerative Medicine Therapies

FDA published draft guidance on June 15, 2022 that describes the Center for Biologics Evaluation and Research’s (CBER) standards recognition program for regenerative medicine therapies (SRP-RMT) to identify Voluntary Consensus Standards (VCS) for the development of regenerative medicine therapy (RMT) products. CBER states that the use of VCS can assist stakeholders in meeting regulatory requirements. “By leveraging stakeholders’ efforts to develop standards, FDA can eliminate costs to the Federal government associated with the development of government-unique standards and promote international harmonization of standards that are acceptable to FDA,” FDA states in the guidance.

The document describes the procedures for evaluating VCS and documenting the use of a standard recognized by CBER. It also answers industry questions about VCS and SRP-RMT.