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

Search:

  

In this Issue

  • Just the FACTs Volume 2
  • FACT Virtual Inspections Update
  • FACT Seeks Inspectors for Virtual Inspections
  • FACT Inspection & Accreditation Virtual Workshop and FACT-ASTCT Quality Boot Camp Draw Record Attendance
  • FACT Congratulates the Recipients of the 2021 ASTCT Awards!
  • Learning from Each Other: Accredited Organizations’ Advice for Preparing for FACT Inspections
  • ISCT to Host Webinar on Apheresis Cellular Therapy Product Procurement for Further Manufacturing
  • ICCBBA Releases Recommendations from Forum 25 Meeting
  • Save the Date! FACT Announces the Apheresis and Processing Accreditation & Inspection Workshop and Quality Boot Camp on May 6-7, 2021

accreditation statistics

As of March 1, 2021

Cellular Therapy Entities

  • Accredited: 240
  • Applicants: 21

Cord Blood Banks

  • Accredited: 58
  • 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In 2018, the United States FDA released six draft guidance documents regarding gene therapy, and the final versions of these documents were released in January 2020. More details can be found in the Just the FACTs newsletter article, FDA Releases Six Draft Guidance Documents for Gene Therapy (2018).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: