Regulatory Information

DRAFT GUIDANCE

Long Term Follow-up After Administration of Human Gene Therapy Products, July 2018
Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry, July 2018
Human Gene Therapy for Hemophilia; Draft Guidance for Industry, July 2018
Human Gene Therapy for Rare Diseases; Draft Guidance for Industry, July 2018
Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry, July 2018

GUIDANCE

Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products, March 2019
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, February 2019
Evaluation of Devices Used with Regenerative Medicine Advanced Therapies, January 2019
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products, June 2017
Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products, January 2016
Guidance for Industry: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research, March 2019
Guidance for Industry: Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products, May 2018
Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception, November 2017
Guidance for Industry and FDA Staff: Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, November 2017
Guidance for Industry: Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271, September 2017
Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), September 2016
Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, August 2016
Guidance for Industry: Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components, August 2016
Guidance for Industry: Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271, March 2016
Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis)
Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System
Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System
Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies, December, 2012
Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies - Small Entity Compliance Guide, December 2012
Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), December 2011
Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion, November 2009
Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications, October 20, 2009
Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications, October 20, 2009
Guidance for Industry: Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection, August 2009
Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests, April 2008
Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), August 2007

REPORTING

Electronic Biological Product Deviation Reporting (eBPDR) Instructions for Using the eBPDR System, July 11, 2009
Procedures for Handling Adverse Reaction Reports Related to "361" Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), March 26, 2008

UPDATES

FACT Submits Comments to CMS Regarding Proposed National Coverage Determination for CAR T-Cell Therapies for Cancer
FACT Submits Comments to the Centers for Medicare & Medicaid Services Regarding Chimeric Antigen Receptor (CAR) T-Cell Therapy for Cancers
FACT Comments on Draft FDA Guidances Related to Regenerative Medicine
FDA and NIH Release Final Template for Clinical Trial Protocols
FDA Update for Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays, August 17, 2009
FDA Update for Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases, August 14, 2009

MEETINGS

FACT Presentation at FDA Public Hearing; Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products, September 12-13, 2016
Cellular, Tissue and Gene Therapies Advisory Committee (CTGAC) Meeting, May 14 - May 15, 2009
Cellular, Tissue and Gene Therapies Advisory Committee (CTGAC) Meeting, March 29 - March 30, 2007

FDA CELLULAR THERAPY LIAISON MEETINGS

FDA Liaison Meeting: October 19, 2016
FDA Liaison Meeting: November 19, 2012
FDA Liaison Meeting: November 29, 2011
FDA Liaison Meeting: October 21, 2010
FDA Liaison Meeting: September 10, 2009
FDA Liaison Meeting: October 17, 2008
FDA Liaison Meeting: February 5, 2008
FDA Liaison Meeting: June 7, 2007
FDA Liaison Meeting: January 4, 2007
FDA Liaison Meeting: June 16, 2006
FDA Liaison Meeting: January 27, 2006
FDA Liaison Meeting: June 24, 2005

CONTACT

FDA Biological Product Deviation Contacts
Manufactures Assistance Branch in the Center for Biologics Evaluation and Research

FAQ

Accreditation Success Story

The University of Utah Blood and Marrow Transplant Program began at the University Hospital in Salt Lake City in 1990. The program has been FACT accredited for 10 years, and offers suggestions for large programs considering FACT accreditation. Read more

FACT: Foundation for the Accreditation of Cellular Therapy

Promoting Quality Patient Care and Laboratory Practice in Cellular Therapies