Fda phacilitate2010final

FDA Regulation of Cellular, Tissue, and Gene Therapies Celia M.Witten, Ph.D., M.D. Director, Office of Cellular, Tissue, and Gene Therapies, FDA Phacilitate Cell and Gene Therapy Forum 2010 Washington, D.C.

Outline ,[object Object],[object Object],[object Object]

FDA Organization ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CBER Organization ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Office of Cellular, Tissue, and Gene Therapies Celia M.Witten, Ph.D, M.D., Director Stephanie Simek, Ph.D., Office Deputy Director Richard McFarland, Ph.D, M.D. Associate Director for Policy Suzanne Epstein, Ph.D., Associate Director for Research Patrick Riggins, Ph.D., Director RPM Division of Cellular and Gene Therapies Raj Puri, Ph.D., M.D., Director Division of Human Tissues Ellen Lazarus, M.D., Director Division of Clinical Evaluation and Pharmacology/Toxicology Vacant

OCTGT Products ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Premarket Review Pathways ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Update on Recent Guidances and Meetings

Workshops 2008-2009 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Workshops 2008-2009, cont’d ,[object Object],[object Object],[object Object],[object Object]

Recent Advisory Committee Meetings ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Safety of Cell Therapies Derived from Human Embryonic Stem Cells CTGT Advisory Committee April 10, 2008 ,[object Object],[object Object],[object Object]

CTGTAC April 10, 2008 Major Considerations ,[object Object],[object Object],[object Object],[object Object]

Cord Blood Guidance – Hot Off the Press ,[object Object],[object Object],[object Object],[object Object]

Phase-in period for IND and BLA requirements, and comment period ,[object Object],[object Object],[object Object]

What is the purpose of the HPC-C Licensure Guidance, and why is there companion Draft HPC-C IND Guidance? ,[object Object],[object Object],[object Object]

Tissue Guidance Documents ,[object Object],[object Object],[object Object],[object Object]

Product-Specific Guidances ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Current Activities/Future Opportunities ,[object Object],[object Object],[object Object],[object Object]

Goals for Tissue Safety ,[object Object],[object Object],[object Object],[object Object]

Relevant Communicable Disease Agents and Diseases Workgroup ,[object Object],[object Object],[object Object]

CBER Pilot Biovigilance Projects ,[object Object],[object Object],[object Object],[object Object],[object Object]

Trends in Cell Therapy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Trends in Gene Therapy ,[object Object],[object Object],[object Object]

International Engagements ,[object Object],[object Object],[object Object],[object Object]

ICH Gene Therapy Discussion Group (GTDG) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

ICH Workshops ,[object Object],[object Object],[object Object],[object Object]

ICH Considerations ,[object Object],[object Object],[object Object]

Published ICH Considerations ,[object Object],[object Object],[object Object]

FDA-EMEA ATMP “Cluster” ,[object Object],[object Object],[object Object]

Regulatory Exchanges ,[object Object],[object Object],[object Object],[object Object]

Contact Information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Fda phacilitate2010final

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