Cellular & Gene Therapy Publications
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- FDA 101: Human Gene Therapy - 2/26/2008
- Human Gene Therapies, Novel Product Development: Q & A with Celia Witten, Ph,D., M.D. - 10/15/2007
- Human Gene Therapy--Harsh Lessons, High Hopes - 9-10/2000
Federal Register:
- Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products; Notice - 10/14/1993
Guidance:
- Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products - 10/9/2008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
- Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products - 2/11/2008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- Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage - 7/6/2007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
- Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Iformation for Human Gene Therapy Investigational New Drug Applications (INDs) - 11/8/2004
- Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug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
- Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy - 3/30/1998
HHS News:
Information Sheets:
Letters to Industry/Healthcare Professionals:
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Lymphocyte Immune Therapy (LIT) Letter - 1/30/2002
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 - (Text), (PDF)
- Dear Gene Therapy IND or Master File Sponsor Letter - 3/6/2000 - (Text), (PDF)
- Dear Gene Therapy IND Sponsor / Principal Investigator Letter - 11/5/1999 - (Text), (PDF)
- FDA Letter to Institutional Review Boards on Human Cloning - 10/26/1998
Orphan Drug list:
Other:
- Prohibition on Federal Funding for Cloning of Human Beings - 3/4/1997
- Proposed Approach to Regulation of Cellular and Tissue-Based Products - 2/28/1997 - (PDF), (Text)
- Reinventing the Regulation of Human Tissue - 2/1997
- Table - (PDF) - Proceedings of FORUM 96: Gene Therapy - 7/1996 - Transcript - (PDF), (Text)
Talk Papers:
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FDA Statement on Gene Therapy Clinical Trial - 7/26/2007
- FDA Advisory Committee Discusses Steps for Potentially Continuing Certain Gene Therapy Trials That Were Recently Placed on Hold - 2/28/2003
- FDA Places Temporary Halt On Gene Therapy Trials Using Retroviral Vectors In Blood Stem Cells - 1/14/2003
- New Initiatives to Protect Participants in Gene Therapy Trials - HHS NEWS - 3/7/2000