01.14.21

FACT Update: New Editions of FACT-JACIE Hematopoietic Cell Therapy and FACT Immune Effector Cell Standards to be Published in May

New Editions of FACT-JACIE Hematopoietic Cell Therapy and FACT Immune Effector Cell Standards to be Published in May

The FACT-JACIE Standards Committee, led by Paul Eldridge, PhD, is completing the final review of the draft eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. FACT committee representatives are also nearing completion of the draft second edition FACT Standards for Immune Effector Cells.

FACT thanks the many participants of the public comment period for providing useful feedback on the drafts. Approximately 770 comments, submitted by 78 participants from 20 countries, enriched the Standards development process and edits have been made in response when appropriate. FACT will provide a response to comments at the time of final publication of the Standards.

The updated editions will be published by May 17, 2021. Following a 90-day transition period, the requirements will be effective on August 16, 2021. To receive announcements of the publications and direct links to the new Standards, Accreditation Manual, and associated documents, subscribe for the FACT newsletter by creating an account at www.factwebsite.org.

Register for the FACT Inspection and Accreditation Workshop and the FACT-ASTCT Quality Boot Camp! 

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