The Foundation for the Accreditation of Cellular Therapy (FACT) has published a draft of the 1st edition FACT Standards for Immune Effector Cell Administration for inspection and public comment. Comments will be accepted for a 60-day period from July 12, 2016 through September 9, 2016. These Standards are intended to promote quality in administration of immune effector cells and will be incorporated into a voluntary FACT accreditation in this field.

These Standards apply to immune effector cells used to elicit an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.

The following documents are available for review:

  1. Request for Public Comments on Draft 1st Edition Immune Effector Cell Standards: This document provides important information regarding the scope of the Standards.
  2. Draft FACT Standards for Immune Effector Cell Administration, 1st Edition: This document includes the entire set of requirements proposed for implementation.
  3. Draft FACT Immune Effector Cell Accreditation Manual, 1st Edition: This document provides guidance information to explain requirements, describe the types of evidence that may be required, and outline examples of ways to comply.

To submit comments regarding the draft 1st edition FACT Immune Effector Cell Standards, follow the steps below. Comments will be accepted through September 9, 2016.

  1. Access the Comment Form at http://goo.gl/forms/HCgXvDuG3CoAPWoz2.
  2. Type in your contact information and comments on the form. Fill in all fields so that FACT fully understands your position.
  3. Submit the form when finished. Once the form is submitted, it cannot be changed. However, additional comments may be submitted by completing the form again. There is no limit to the number of forms that can be submitted.
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