FDA Cell Therapy Guidance

March 7, 2014 | by |

February 2019. Food and Drug Administration.  Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Guidance for Industry.  U.S. Department of Health and Human Services, Rockville, Maryland.

February 2019. Food and Drug Administration.  Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry. U.S. Department of Health and Human Services, Rockville, Maryland.

July 2018. Food and Drug Administration. Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Draft Guidance for Industry. U.S. Department of Health and Human Services, Rockville, Maryland.

July 2018. Food and Drug Administration. Long Term Follow-up After Administration of Human Gene Therapy Products; Draft Guidance for Industry. U.S. Department of Health and Human Services, Rockville, Maryland.

July 2018. Food and Drug Administration. Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry. U.S. Department of Health and Human Services, Rockville, Maryland.

July 2018. Food and Drug Administration. Human Gene Therapy for Hemophilia; Draft Guidance for Industry. U.S. Department of Health and Human Services, Rockville, Maryland.

July 2018. Food and Drug Administration.  Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.  U.S. Department of Health and Human Services, Rockville, Maryland.

July 2018. Food and Drug Administration. Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry. U.S. Department of Health and Human Services, Rockville, Maryland.

December 2017. Food and Drug Administration. 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. U.S. Department of Health and Human Services, Rockville, Maryland.

November 2017. Food and Drug Administration.  Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception; Guidance for Industry. U.S. Department of Health and Human Services, Rockville, Maryland.

September 2017. Food and Drug Administration. 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. U.S. Department of Health and Human Services, Rockville, Maryland.

September 2016. Food and Drug Administration. Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry. U.S. Department of Health and Human Services, Rockville, Maryland.

August 2015. Food and Drug Administration. Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry. U.S. Department of Health and Human Services, Rockville, Maryland.

December 2015. Food and Drug Administration.  Draft  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. U.S. Department of Health and Human Services, Rockville, Maryland.

August 2015. Food and Drug Administration. Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products. U.S. Department of Health and Human Services, Rockville, Maryland.

June 2015. Food and Drug Administration. Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products. U.S. Department of Health and Human Services, Rockville, Maryland.

December 2014. Food and Drug Administration. Draft Guidance for Industry: Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products. U.S. Department of Health and Human Services, Rockville, Maryland.

December 2014. Food and Drug Administration. Draft Guidance for Industry: Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations. U.S. Department of Health and Human Services, Rockville, Maryland.

October 2014. Food and Drug Administration. Draft Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception. U.S. Department of Health and Human Services, Rockville, Maryland.

June 2014. Food and Drug Administration. Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products. U.S. Department of Health and Human Services, Rockville, Maryland.

March 2014. Food and Drug Administration. 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. U.S. Department of Health and Human Services, Rockville, Maryland.

March 2014. Food and Drug Administration. 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. U.S. Department of Health and Human Services, Rockville, Maryland.

November 2013. Food and Drug Administration. Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products. U.S. Department of Health and Human Services, Rockville, Maryland.

December 2011. Food and Drug Administration. Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage. U.S. Department of Health and Human Services, Rockville, Maryland.

October 2011. Food and Drug Administration. Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines. U.S. Department of Health and Human Services, Rockville, Maryland.

June 2011. Food and Drug Administration. 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. U.S. Department of Health and Human Services, Rockville, Maryland.

January 2011. Food and Drug Administration. Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products. U.S. Department of Health and Human Services, Rockville, Maryland.

October 2010. Food and Drug Administration. Guidance for Industry: Cellular Therapy for Cardiac Disease. U.S. Department of Health and Human Services, Rockville, Maryland.

October 2009. Food and Drug Administration. Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications. U.S. Department of Health and Human Services, Rockville, Maryland.

 September 2009. Food and Drug Administration. Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products. U.S. Department of Health and Human Services, Rockville, Maryland.

April 2008. Food and Drug Administration. Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs). U.S. Department of Health and Human Services, Rockville, Maryland.

August 2007. Food and Drug Administration. Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). U.S. Department of Health and Human Services, Rockville, Maryland.

March 1998. Food and Drug Administration. Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy. U.S. Department of Health and Human Services, Rockville, Maryland.

Food and Drug Administration. Blood Guidance Documents. U.S. Department of Health and Human Services, Rockville, Maryland.

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