Should 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.
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Draft Guidance for Industry3/2022
Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry3/2022
Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency; Guidance for Industry and Health Care Professionals12/2021
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry9/2021
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Draft Guidance for Industry9/2021
Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency; Guidance for Industry1/2021
Human Gene Therapy for Neurodegenerative Diseases; Draft Guidance for Industry1/2021
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Guidance for Industry1/2020
Long Term Follow-up After Administration of Human Gene Therapy Products; Guidance for Industry1/2020
Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry1/2020
Human Gene Therapy for Hemophilia; Guidance for Industry1/2020
Human Gene Therapy for Rare Diseases; Guidance for Industry1/2020
Human Gene Therapy for Retinal Disorders; Guidance for Industry1/2020
Evaluation of Devices Used with Regenerative Medicine Advanced Therapies;Guidance for Industry2/2019
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions;Guidance for Industry2/2019
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 StaffUpdated: 12/2017
Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception; Guidance for Industry11/2017
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 Industry9/2017
Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry9/2016
Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry8/2015
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry6/2015
Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry3/2015
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 System3/2014. (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 Staff3/2014. (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 Cartilage12/2011. (This guidance finalizes the draft guidance of the same title dated July 2007.)
Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines10/2011. (This guidance finalizes the draft guidance of the same title dated September 2009.)
Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products1/2011. (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 Products9/2009
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 Industry8/2007
Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy3/1998
12/10/2021
More here:
Cellular & Gene Therapy Guidances | FDA
- New gene offers hope for preventive medicine against fractures [Last Updated On: September 18th, 2012] [Originally Added On: September 18th, 2012]
- Colon Cancer Gene Database May Assist Research Efforts [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Researchers discover gene that causes deafness [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Gene Study Yields New Clues to Breast Cancer [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Gene key to chemotherapy efficacy [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Gene clues offer new hope for treating breast cancer [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Gene that causes deafness pinpointed [Last Updated On: October 1st, 2012] [Originally Added On: October 1st, 2012]
- Gene that causes a form of deafness discovered [Last Updated On: October 1st, 2012] [Originally Added On: October 1st, 2012]
- Novel gene associated with Usher syndrome identified [Last Updated On: October 2nd, 2012] [Originally Added On: October 2nd, 2012]
- Translational Regenerative Medicine: Market Prospects 2012-2022 [Last Updated On: October 2nd, 2012] [Originally Added On: October 2nd, 2012]
- Two-day test can spot gene diseases in newborns [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Fast Gene Screen May Help Sick Babies [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Gene therapies need new development models [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Rapid gene machines used to find cause of newborn illnesses [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Gene behind many spontaneous breast cancers identified [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Gene responsible for many spontaneous breast cancers identified [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Two-day test can spot gene diseases in newborns - Wed, 03 Oct 2012 PST [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Researchers Discover Gene Defect Linked to Deafness [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Gene diseases in newborns unveiled quicker [Last Updated On: October 4th, 2012] [Originally Added On: October 4th, 2012]
- Quicker gene test may help babies - Thu, 04 Oct 2012 PST [Last Updated On: October 4th, 2012] [Originally Added On: October 4th, 2012]
- Rapid gene-mapping test may diagnose disease in newborns [Last Updated On: October 5th, 2012] [Originally Added On: October 5th, 2012]
- 2-day test can spot gene diseases in newborns [Last Updated On: October 5th, 2012] [Originally Added On: October 5th, 2012]
- Gene diseases in newborns spotted with 2-day test [Last Updated On: October 5th, 2012] [Originally Added On: October 5th, 2012]
- Rare Gene Deletion Tied To Psychiatric Disease And Obesity [Last Updated On: October 10th, 2012] [Originally Added On: October 10th, 2012]
- Mount Sinai researchers discover gene signature that predicts prostate cancer survival [Last Updated On: October 10th, 2012] [Originally Added On: October 10th, 2012]
- Test Spots Newborn Gene Disease [Last Updated On: October 10th, 2012] [Originally Added On: October 10th, 2012]
- Gene signature predicts prostate cancer survival [Last Updated On: October 11th, 2012] [Originally Added On: October 11th, 2012]
- Researchers Discover Gene Signature that Predicts Prostate Cancer Survival [Last Updated On: October 11th, 2012] [Originally Added On: October 11th, 2012]
- Bioethics Panel Urges More Gene Privacy Protection [Last Updated On: October 11th, 2012] [Originally Added On: October 11th, 2012]
- High Levels of Blood-Based Protein Specific to Mesothelioma [Last Updated On: October 11th, 2012] [Originally Added On: October 11th, 2012]
- Gene clues to help tackle skin disease [Last Updated On: October 15th, 2012] [Originally Added On: October 15th, 2012]
- Additive effect of small gene variations can increase risk of autism spectrum disorders [Last Updated On: October 15th, 2012] [Originally Added On: October 15th, 2012]
- 2-gene test predicts which patients with heart failure respond best to beta-blocker drug [Last Updated On: October 16th, 2012] [Originally Added On: October 16th, 2012]
- Two-gene test predicts which patients with heart failure respond best to beta-blocker drug [Last Updated On: October 16th, 2012] [Originally Added On: October 16th, 2012]
- Gene Linked to Kidney Failure [Last Updated On: October 17th, 2012] [Originally Added On: October 17th, 2012]
- Nanoparticles seen as gene therapy advance [Last Updated On: October 17th, 2012] [Originally Added On: October 17th, 2012]
- Stem Cell Therapy for Sickle Cell Anemia - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Sickle Cell Anemia: Stem Cell Gene Therapy - Donald Kohn - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Finding A Cure For Cancer with Dr. Aaron Rapoport - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- First gene therapy to go on sale in Europe in 2013: company [Last Updated On: November 7th, 2012] [Originally Added On: November 7th, 2012]
- Nanomedicine: Infectious Diseases, Immunotherapy, Diagnostics, Antifibrotics, Toxicology And Gene Me - Video [Last Updated On: November 14th, 2012] [Originally Added On: November 14th, 2012]
- Stress gene linked to heart attack – Study [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- Why not gift yourself with gene test this Christmas? [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- "Stress gene" may raise heart attack risk in healthy people [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- 'Stress Gene' Ups Heart Attack, Death Risk [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- Common disorders: It's not the genes themselves, but how they are controlled [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- What is a gene? - Genetics Home Reference [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- Gene Medicine | Business Outline | About Us | TAKARA BIO INC. [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- Gene Therapy Clinical Trials Worldwide [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- Genentech - Official Site [Last Updated On: December 21st, 2013] [Originally Added On: December 21st, 2013]
- Gene Therapy - American Medical Association [Last Updated On: December 23rd, 2013] [Originally Added On: December 23rd, 2013]
- Researchers identify gene that influences the ability to remember faces [Last Updated On: December 24th, 2013] [Originally Added On: December 24th, 2013]
- Gene That Influences Bonding Also Found To Impact Facial Recognition [Last Updated On: December 24th, 2013] [Originally Added On: December 24th, 2013]
- Gene Therapy Method Targets Tumor Blood Vessels [Last Updated On: December 24th, 2013] [Originally Added On: December 24th, 2013]
- Latin Americans inherited diabetes gene risk from Neanderthals [Last Updated On: December 26th, 2013] [Originally Added On: December 26th, 2013]
- Gene that influences the ability to remember faces identified [Last Updated On: December 30th, 2013] [Originally Added On: December 30th, 2013]
- Study supports a causal role in narcolepsy for a common genetic variant [Last Updated On: January 2nd, 2014] [Originally Added On: January 2nd, 2014]
- Increasing Investments in Molecular Biology Research Drives the Market for DNA Gene Chips, According to a New Trend ... [Last Updated On: January 2nd, 2014] [Originally Added On: January 2nd, 2014]
- Loss of Function of a Single Gene Linked to Diabetes in Mice [Last Updated On: January 3rd, 2014] [Originally Added On: January 3rd, 2014]
- Gene Medicine and Health [Last Updated On: January 3rd, 2014] [Originally Added On: January 3rd, 2014]
- Gene Therapy - Nature [Last Updated On: January 5th, 2014] [Originally Added On: January 5th, 2014]
- KidsHealth for Parents - Gene Therapy and Children [Last Updated On: January 5th, 2014] [Originally Added On: January 5th, 2014]
- Gene Patent Case Fuels U.S. Court Test of Stem Cell Right [Last Updated On: January 6th, 2014] [Originally Added On: January 6th, 2014]
- Gene Mutation Increases Certain Health Risks For Blacks, Study Finds [Last Updated On: January 6th, 2014] [Originally Added On: January 6th, 2014]
- Single faulty gene causes major type 2 diabetes symptom in mice [Last Updated On: January 6th, 2014] [Originally Added On: January 6th, 2014]
- No 'brakes' -- Study finds mechanism for increased activity of oncogene in certain cancers [Last Updated On: January 6th, 2014] [Originally Added On: January 6th, 2014]
- AML score that combines genetic and epigenetic changes might help guide therapy [Last Updated On: January 9th, 2014] [Originally Added On: January 9th, 2014]
- Stem cell research identifies new gene targets in patients with Alzheimer's disease [Last Updated On: January 9th, 2014] [Originally Added On: January 9th, 2014]
- 14 new gene targets in Alzheimer’s identified [Last Updated On: January 10th, 2014] [Originally Added On: January 10th, 2014]
- Scientists uncover new target for brain cancer treatment [Last Updated On: January 11th, 2014] [Originally Added On: January 11th, 2014]
- Tweaking MRI to Track Creatine May Spot Heart Problems Earlier, Penn Medicine Study Suggests [Last Updated On: January 13th, 2014] [Originally Added On: January 13th, 2014]
- RSNA: Gene Variation Associated with Brain Atrophy in Mild Cognitive Impairment [Last Updated On: January 14th, 2014] [Originally Added On: January 14th, 2014]
- Keeping Stem Cells Pluripotent [Last Updated On: January 14th, 2014] [Originally Added On: January 14th, 2014]
- Gene variation associated with brain atrophy in mild cognitive impairment [Last Updated On: January 14th, 2014] [Originally Added On: January 14th, 2014]
- Genes: MedlinePlus Medical Encyclopedia - National Library of ... [Last Updated On: January 15th, 2014] [Originally Added On: January 15th, 2014]
- Gene Therapy May Restore Sight in People With Rare Blinding Disease [Last Updated On: January 16th, 2014] [Originally Added On: January 16th, 2014]
- Gene therapy treats blindness [Last Updated On: January 16th, 2014] [Originally Added On: January 16th, 2014]
- New Genetic Clue to Lupus Is Found [Last Updated On: January 17th, 2014] [Originally Added On: January 17th, 2014]
- New Gene Machine Could Mean More Accurate Diagnosis [Last Updated On: January 18th, 2014] [Originally Added On: January 18th, 2014]
- Same cell death pathway involved in three forms of blindness, study finds [Last Updated On: January 18th, 2014] [Originally Added On: January 18th, 2014]
