Last Chance – Submit Your Comments on the Draft FACT Common Standards by May 11!
The draft fourth edition of the FACT Common Standards for Cellular Therapies is available for public comment through May 11, 2026.
The objective of the FACT Common Standards is to promote quality medical and laboratory practice in a broad range of cellular therapies. These Standards represent basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application throughout product development and clinical trials. They are applied to cellular therapy programs that collect, process, or administer cellular therapies that are not yet ready for more specific standardization.
As the field of cellular therapy continues to evolve, our goal for each new edition of the Standards is to accurately capture and reflect those changes to maintain a relevant and valuable resource for programs. Information received during the public comment period is essential to achieving this goal. We encourage you to submit comments on the draft Standards as it provides an opportunity for the community at large to directly share feedback, and each comment is reviewed by the Standards Committee.
These Standards also provide a foundation for FACT’s other sets of Standards for hematopoietic progenitor cell transplantation, immune effector cell therapy, and cord blood banking, and feedback received on the Common Standards will be informative for the other more specific sets of Standards.
Download the following documents located at the bottom of the FACT Standards web page:
- Draft Fourth Edition Common Standards
- Redline Draft Fourth Edition Common Standards
- Summary of Changes (high-level overview)
The public comment survey and additional instructions are available at:
https://redcap.link/Common4-public-comment.
There is no limit to the number of comments that can be submitted. This survey allows up to ten (10) comments per section. To submit additional comments, please start a new survey.
For questions regarding the survey, please contact Standards@factglobal.org.
