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Vaccines, Blood & Biologics
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Resources for You
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Cellular & Gene Therapy Guidances
We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within Guidances, Rules and other documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.
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Cellular & Gene Therapy Guidance Documents
- Draft Guidance for Industry: Somatic Cell Therapy for Cardiac Disease
03/2009 - Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products
10/9/2008 - 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4/9/2008 - Draft Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
3/2008 - Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products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8/8/2007 - Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
7/6/2007 - 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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Food and Drug Administration
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Rockville, MD 20852-1448
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