SCB Supports Launch of FDA CBER Standards Recognition Program
With the exciting announcement of the upcoming FDA Center for Biologics Evaluation and Research (CBER) standards recognition program focused on regenerative medicine therapies, members of the regenerative community have many questions about what to expect. SCB has taken a leading role in increasing community understanding of the program and gathering feedback on the draft standards recognition program guidance to ensure that stakeholder perspectives are heard and considered by the FDA.
Educating and Gathering Input from the Community
The standards recognition program is intended to help regenerative medicine stakeholders identify standards FDA has assessed in advance for use regulatory submissions. To broaden awareness and understanding of the program, we:
Hosted a webinar to walk through the new guidance, answer participant questions, and solicit feedback.
Developed a Q&A addressing common questions about the standards recognition program and issued a community survey to gather broader feedback.
Consolidating Feedback for FDA
The feedback we have heard on the FDA guidance has been highly positive, with stakeholders expressing support for the program and noting that it will be valuable in facilitating the development of safe and effective regenerative medicine products. We developed two letters outlining the response to share with FDA:
The first letter outlines individual stakeholder comments, concerns, and questions, including those received during the webinar.
The second letter confirms support for the program at an organization level from a broad spectrum of groups involved in standards development and acknowledges the importance of early FDA involvement in the standards development process. In addition, it notes that the types of standards most useful to the regenerative medicine community may differ from those recognized by the existing Center for Devices and Radiological Health (CDRH) standards recognition program. The latter letter was co-signed by representatives of the following organizations to express their support:
Association for the Advancement of Blood & Biotherapies (AABB)
The Alliance for Regenerative Medicine (ARM)
Advanced Regenerative Manufacturing Institute (ARMI) / BioFabUSA
ASTM International
Biotechnology Innovation Organization (BIO)
Foundation for the Accreditation of Cellular Therapy (FACT)
Hybrid Concepts International, LLC
International Council for Commonality in Blood Banking Automation (ICCBBA)
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
Parenteral Drug Association (PDA)
Pfizer
Synthego Inc.
Next Steps
As we move closer to the official launch of the standards recognition program—which will occur once FDA has finalized the guidance—SCB will continue to keep members of the regenerative medicine community apprised as to how to leverage the program to streamline their regulatory submissions. In addition, we plan to add functionality to the Regenerative Medicine Standards Portal identifying the standards that have been formally recognized by FDA to enable stakeholders to quickly and easily find these standards.
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