FACT Submits Comments to Governmental Agencies

Posted in :: 2018 Volume 3 :: Wednesday, August 22nd, 2018

FACT-accredited organizations are regulated by several governmental agencies around the world in relation to quality and safety of cellular therapy products and reimbursement. When draft regulations or guidance documents are released, FACT committees review the information and submit comments as applicable to the scope of FACT accreditation. In the past decade, comments have been submitted to agencies in the United States, Australia, and Europe. The FACT Global Affairs Committee also supports cellular therapy leaders in developing countries to encourage use of FACT Standards.

So far this year, FACT has submitted comments on three topics to two agencies in the United States:

FACT also plans to review the recently published FDA draft guidance documents for gene therapies. These comments are due by October 10, 2018. If you have input you would like FACT to consider for inclusion, submit those to Kara Wacker at kwacker@unmc.edu by August 31, 2018.