Feedback Needed: Updated Regenerative Medicine Standards Landscape Report (Spring 2019)

A draft version of the updated Spring 2019 Regenerative Medicine Standards Landscape is now available and open for comments through April 30, 2019.

The first iteration of the Regenerative Medicine Standards Landscape was co-authored by Nexight Group and SCB in 2018, with funding from the U.S. Food and Drug Administration (FDA). This document is intended to provide a single repository of existing and in-development regenerative medicine standards that regenerative medicine stakeholders can easily reference to identify standards that apply to their work and to inform assessments of other areas where standards could benefit the field. The report currently lists more than 200 existing and in-progress standards, including more than 70 supportive standards applicable to one or more of the cell therapy, gene therapy, or tissue engineering sectors.

Key changes in the Spring 2019 update include:

  • Added relevant standards, including six standards from the Parenteral Drug Association (PDA) and eight standards from the European Directorate for the Quality of Medicines and Healthcare (EDQM)

  • Updated other standards in the report to improve accuracy and reflect current status

  • Removed the section on needed standards, which will become part of the Community Perspectives: Needed Standards in Regenerative Medicine report planned for release at the end of April

  • Made general edits to the language and content of the document to align with stakeholder feedback and latest research

Provide Your Feedback

Because the Regenerative Medicine Standards Landscape is an evolving document, we are seeking feedback that can help us improve the report’s accuracy and completeness. We welcome you to view the full updated report and provide your input. Feedback can include:

  • Suggestions on additional standards or SDOs to include

  • Corrections to existing standards or other report content

  • Ways to better organize or structure report contents

  • Any other feedback you feel would improve the report

Please send your suggestions for improving the report to Allison Getz (agetz@regenmedscb.org) by April 30, 2019.