Vaccines, Blood & Biologics
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Cellular & Gene Therapy Guidances
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.
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Cellular & Gene Therapy Guidance Documents
Draft Guidance of Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products (PDF - 168KB)
November 2012. (This guidance, when finalized, will supersede the recommendations in section VIII in the final guidance entitled “Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy” dated March 1998 (Ref. 1).Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (PDF - 157KB)
December 2011. (This guidance finalizes the draft guidance of the same title dated July 2007.)Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines (PDF - 75KB)
10/2011. (This guidance finalizes the draft guidance of the same title dated September 2009.)Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications. (PDF - 104KB)Final Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products (PDF - 311KB)
January 2011. (This guidance finalizes the draft document of the same name, dated October 2008.)Guidance for Industry: Cellular Therapy for Cardiac Disease
October 2010. (This guidance finalizes the draft guidance entitled “Guidance for Industry: Somatic Cell Therapy for Cardiac Disease” dated March 2009 (April 2, 2009, 74 FR 14992).Assay Development for Immunogenicity Testing of Therapeutic Proteins (PDF - 161KB)Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 462KB)
10/2009Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products 09/2009 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) 4/9/2008 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) 4/9/2008 Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products 2/11/2008 Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products 8/8/2007 Guidance for Industry: Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events 11/28/2006 Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors 11/28/2006 Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy 3/30/1998 Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products (TXT - 59KB)01/1997
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