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accreditation statistics

2018 Third Quarter Accreditations

Cellular Therapy Entities

  • Accredited: 231
  • Applicants: 6

Cord Blood Banks

  • Accredited: 54
  • Applicants: 9

During the third quarter of 2018, 20 entities received FACT accreditation. For details regarding these accreditations, view the full accreditation report.

A complete list of accredited organizations can be found at www.factwebsite.org.

FACT Submits Comments Regarding Draft FDA Guidance on Regenerative Medicine

Posted in :: 2018 Volume 1 :: Thursday, February 15th, 2018

In November 2017, the FDA released a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies, through the publication of four guidance documents. Two of these documents were finalized, and two are open for public comment.

Draft documents that were open for public comment until February 14, 2018 include:

Related documents published in final form include:

FACT supports the FDA’s efforts to clarify and streamline its regulation of regenerative medicine therapies, and submitted comments organized into two sections: 1) the role of FACT accreditation in advancing cellular therapy for regenerative medicine and 2) specific comments about the guidance documents themselves.