FACT Standards Available for Public Review and Comment
FACT Common Standards for Cellular Therapies
The Foundation for the Accreditation of Cellular Therapy (FACT) published the draft Third Edition FACT Common Standards for Cellular Therapies for inspection and public comment. These Standards represent the basic fundamentals of cellular therapy that can be applied to any cell source or therapeutic application and are intended to be used throughout product development and clinical trials.
These
FACT Common Standards for Cellular Therapies are not intended to suffice
for hematopoietic cellular therapy programs, immune effector cell therapy
services, or cord blood banks. More detailed and specific standards exist for
these disciplines that include the relevant requirements from this document,
and FACT accreditation in these disciplines is based on the specific standards.
The current editions of these more specific Standards are available at www.factwebsite.org:
- FACT-JACIE International
Standards for Hematopoietic Cellular Therapy Product Collection, Processing,
and Administration.
- NetCord-FACT International
Standards for Cord Blood Collection, Banking, and Release for
Administration.
- FACT Standards for Immune
Effector Cells.
The final third edition Common Standards will be
published in March 2022 and will become effective in June 2022.
Description and Instructions for Review and Comment
Summary of Changes
Draft Third Edition FACT Common Standards for Cellular Therapies
Comments regarding the draft Third Edition FACT Common Standards for Cellular Therapies can be submitted by accessing the Comment Form. Comments will be accepted through September 30, 2021.
FACT Standards for Immune Effector Cells
The Foundation for the Accreditation of Cellular Therapy (FACT) published the draft Second Edition FACT Standards for Immune Effector Cells for inspection and public comment. These Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes, but is not limited to, genetically engineered chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.
Description and Instructions for Review and Comment
Summary of Changes
Draft Second Edition FACT Standards for Immune Effector Cells
Comments regarding the draft Second Edition FACT Standards for Immune Effector Cells can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.
Ongoing Feedback on Current Standards
Comments from the public regarding the current Standards and/or Accreditation Manuals may be submitted at any time. Intermittently, it is necessary update the Standards or Accreditation Manuals based on changes to applicable laws and regulations, field experience, or other reasons. FACT has a process to accommodate needed changes between editions which can be found in the Establishing and Reviewing Standards policy.