Return to FACT
Just the FACTs Home
    • submit an article
    • past newsletters
    • article index

In This Issue

  • Just the FACTs, 2020 Volume 2
  • COVID-19 Update: FACT Accreditation
  • FDA Releases Suggestions for Evaluating Donors for Coronavirus
  • FACT Events at the 2020 TCT Meetings Were a Success!
  • SBTMO meeting at TCT
  • Mark Litzow Receives Service Award
  • Comments Requested on Standard Labeling Proposed for Apheresis Collection Products: Due April 24, 2020
  • FDA Finalizes Gene Therapy Guidances
  • 2020 FACT-ASTCT Quality Manager Engagement and Resiliency Survey
  • Education Events

accreditation statistics

As of December 8, 2020

Cellular Therapy Entities

  • Accredited: 240
  • Applicants: 22

Cord Blood Banks

  • Accredited: 57
  • Applicants: 8

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

FDA Finalizes Gene Therapy Guidances

Posted in :: 2020 Volume 2 :: Monday, March 16th, 2020

In 2018, the United States FDA released six draft guidance documents regarding gene therapy, and the final versions of these documents were released in January 2020. More details can be found in the Just the FACTs newsletter article, FDA Releases Six Draft Guidance Documents for Gene Therapy (2018).

The final documents can be accessed online:

  • Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Guidance for Industry
  • Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry
  • Long Term Follow-Up After Administration of Human Gene Therapy Products; Guidance for Industry
  • Human Gene Therapy for Retinal Disorders; Guidance for Industry
  • Human Gene Therapy for Rare Diseases; Guidance for Industry
  • Human Gene Therapy for Hemophilia; Guidance for Industry

connect

connect

education

  • FACT Calendar
  • FACT Store
  • FACT Standards

Search: