Tissue Related Documents
Human Cell Products
- Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs) - 8/15/2003 - (PDF, 106 KB)
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Lymphocyte Immune Therapy (LIT) Letter - 1/30/2002 - (PDF, 236 KB)
Note: the correct CBER contact telephone number is 301-827-5102
- Letter to Sponsors / Researchers - Human Cells Used in Therapy Involving the Transfer of Genetic Material By Means Other Than the Union of Gamete Nuclei - 7/6/2001
- Letter to Sponsors / Researchers - Fetal Cellular or Tissue Products In Human Clinical Studies - 11/30/2000 - (PDF, 156 KB)
- ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin - 9/24/1998 - (PDF, 89 KB)
- ICH Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products - 9/21/1998 - (PDF, 47 KB)
- Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy - 3/30/1998 - (PDF, 78 KB)
- Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use - 2/28/1997 - (PDF, 140 KB)
- Guidance For the Submission of Chemistry, Manufacturing and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products - 1/10/1997 -
- Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated ex vivo and Intended for Structural Repair or Reconstruction - 5/1996 - (PDF, 28 KB)
- FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products - 4/1996 - (PDF, 25 KB)
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