Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Biologics Guidances

Biologics Guidances

                        Allergenics Guidances
          Blood Guidances
          Cellular & Gene Therapy Guidances
          Tissue Guidances
          Vaccine and Related Biological Product Guidances
          Xenotransplantation Guidances


                        General Biologics Guidances Home
          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Biologics Guidances
          Cellular & Gene Therapy GuidancesBiologics Guidances Cellular & Gene Therapy Guidances
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintShould you find a link that does not work within any Guidance document, Rule or other document posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA.

Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry
	1/2024
	Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Guidance for Industry
	1/2024
	Potency Assurance for Cellular and Gene Therapy Products; Draft Guidance for Industry
	12/2023
	For a high-level overview of this guidance document, please view this recorded webinar featuring Dr. Matthew Klinker, Cell Therapy Branch 2 Chief, Office of Cellular Therapy and Human Tissues, Office of Therapeutic Products, CBER.
	Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry
	7/2023
	For a high-level overview of this guidance document, please view this recorded webinar featuring Dr. Andrew Byrnes, Gene Transfer & Immunogenicity Branch Chief, Office of Gene Therapy CMC, Office of Therapeutic Products, CBER.
	Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Guidance for Industry
	11/2022
	Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry
	10/2022
	Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry
	9/2021
	Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency; Guidance for Industry
	1/2021
	Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Guidance for Industry
	1/2020
	Long Term Follow-up After Administration of Human Gene Therapy Products; Guidance for Industry
	1/2020
	Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry
	1/2020
	Human Gene Therapy for Hemophilia; Guidance for Industry
	1/2020
	Human Gene Therapy for Rare Diseases; Guidance for Industry
	1/2020
	Human Gene Therapy for Retinal Disorders; Guidance for Industry
	1/2020
	Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry
	2/2019
	Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Guidance for Industry
	2/2019
	Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff
	Updated: 12/2017
	Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception; Guidance for Industry
	11/2017
	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; Guidance for Industry
	9/2017
	Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry
	9/2016
	Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry
	8/2015
	Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry
	6/2015
	Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry
	3/2015
	Guidance for Industry: BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System
	3/2014. (This guidance finalizes the draft guidance of the same title dated June 2013.)
	IND 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 FDA Staff
	3/2014. (This guidance finalizes the draft guidance of the same title dated June 2013.)
	Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products
	(This guidance finalizes the draft guidance entitled “Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products” dated November 2012) 11/2013
	Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
	12/2011. (This guidance finalizes the draft guidance of the same title dated July 2007.)
	Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines
	10/2011. (This guidance finalizes the draft guidance of the same title dated September 2009.)
	Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products
	1/2011. (This guidance finalizes the draft document of the same name, dated October 2008.)
	Guidance for Industry: Cellular Therapy for Cardiac Disease
	(This guidance finalizes the draft guidance entitled “Guidance for Industry: Somatic Cell Therapy for Cardiac Disease” dated March 2009 (April 2, 2009, 74 FR 14992). 10/2010.
	Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
	9/2009
	Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
	4/2008
	Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry
	8/2007
	Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy
	3/1998

                                                                                  Content current as of:
      01/29/2024
              
              
Regulated Product(s)
		 Biologics
			  			     			  						              
			
			 
			  Gene TherapyBiologics Guidances

          
                        Allergenics Guidances
          Blood Guidances
          Cellular & Gene Therapy Guidances
          Tissue Guidances
          Vaccine and Related Biological Product Guidances
          Xenotransplantation Guidances


                        General Biologics Guidances
 Subscribe for CBER Updates
                        Get e-mail updates on What’s New at CBER!
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop