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Core Facilities

Cell Manipulation

Resources and Links for Investigators

Resources and Links for Investigators

Organizations

Center for Biologics Evaluation and Research (Food and Drug Administration)
National Institutes of Health Office of Biotechnology Activities
Code of Federal Regulation (National Archives and Records Administration)
International Society for Cellular Therapy
Foundation for the Accreditation of Cellular Therapy
American Association of Blood Banks
American Society of Hematology
National Marrow Donation Program
Joint Program in Transfusion Medicine

Cellular and Gene Therapy Research

Circular of Information for Cellular Therapy Products (2009, most current version)
New Cell Therapy Development and Review Policy (2005)
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 (This guidance finalizes the draft guidance of the same title dated July 2007.)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 (This guidance finalizes the draft guidance of the same title dated September 2009.)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 (This guidance finalizes the draft guidance entitled “Guidance for Industry: Somatic Cell Therapy for Cardiac Disease” dated March 2009 (April 2, 2009, 74 FR 14992).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: 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)1 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
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

Tissue Research

Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). (PDF - 265KB) 12/2011
Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container Updated: 3/2011
Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products (TXT - 59KB)

Investigational New Drug (IND) Process and Requirements

Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations
Drug Development and Review Definitions
Federal Regulations for Clinical Investigators
IND Forms and Instructions
Information for Clinical Investigators (INDs)
Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials
Final Rule: IND Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans (9/28/2010)