By Andra Moehring, FACT Standards Development Manager
Congratulations to Dr. Paul Eldridge, FACT Standards Chair, and the FACT Common Standards Steering Committee on publishing the Second Edition FACT Common Standards for Cellular Therapies on March 15, 2019. The Standards will become effective on June 15, 2019.
The Second Edition FACT Common Standards Steering Committee is comprised of 12 representatives who worked for 23 months on the development of the Standards. The committee’s commitment, expertise, and experience is invaluable to the development of these Standards.
The Standards contain important additions and changes to requirements to reflect current processes typical in a cellular therapy program. These changes maintain the relevance of the Standards in the field of cellular therapy.
Public Comment Period
During the 60-day public comment period, 240 comments were submitted by 19 contributors. The committee was responsive to public comments and requests made on behalf of related organizations.
FACT greatly appreciates contributors taking the time to review the draft Standards and submit comments.
Accessing the Standards and Other Resources
The Standards, summary of changes, and crosswalks are available on the FACT website at http://www.factwebsite.org or by using the links provided below:
FACT Common Standards, Second Edition
Purchase Printed Copies
Summary of Changes to FACT Common Standards, Second Edition
FACT Common Standards Crosswalk First to Second Edition
FACT Common Standards Crosswalk Second to First Edition
If you have questions related to the Second Edition FACT Common Standards, contact your FACT Coordinator or submit your questions to firstname.lastname@example.org.
Thank you for all of your contributions!