Regulatory Information

Draft Guidance

Guidance

Reporting

Updates

Meetings

FDA Cellular Therapy Liaison Meetings

Contact

DRAFT GUIDANCE 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Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry, July 2018

Human Gene Therapy for Hemophilia; Draft Guidance for Industry, July 2018

Human Gene Therapy for Rare Diseases; Draft Guidance for Industry, July 2018

Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry, July 2018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: March 05, 2019

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

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