FDA Regulation of Cellular, Tissue, and Gene Therapies.ppt

FDA Regulation of Cellular, Tissue, and Gene Therapies
Celia , ., .
Director, Office of Cellular, Tissue, and Gene Therapies, FDA
Phacilitate Cell and Gene Therapy Forum 2010
Washington, .
1
Outline
Overview of Office and Regulations
Update on Recent Guidances and Meetings
Current Activities/Future Opportunities
2
anization
Office of missioner
Office bination Products
CBER (Center for Biologics Evaluation and Research): ines, blood and blood products, human tissue/tissue products for transplantation, cell therapy, gene therapy, donor screening tests for blood and tissue safety, devices
CDRH (Center for Devices and Radiological Health): devices for treatment, implants, diagnostic devices
CDER (Center for Drug Evaluation and Research): drugs, monoclonal antibodies, therapeutic proteins)
CVM
CFSAN
NCTR
3
anization
Immediate Office of Director
Office of Blood Research and Review
Office of Cellular, Tissue and Gene Therapies
Office of ines Research and Review
Office pliance and Biological Quality
Office of Biostatistics and Epidemiology
Office munication, Training and Manufacturers Assistance
Office of Management
4
Office of Cellular, Tissue, and Gene Therapies
Celia , , ., Director
Stephanie Simek, ., Office Deputy Director
Richard McFarland, , . Associate Director for Policy
Suzanne Epstein, ., Associate Director for Research
Patrick Riggins, ., Director RPM
Division of Cellular and Gene Therapies
Raj Puri, ., ., Director
Division of Human Tissues
Ellen Lazarus, ., Director
Division of Clinical Evaluation and Pharmacology/Toxicology
Vacant
5
OCTGT Products
Cellular therapies
Tumor ines and immunotherapy
Gene therapies
Tissue and tissue based products
Xenotransplantation bination products
Devices used for cells/tissues
Donor screening tests (for use with cadaveric blood samples)
6
Premarket Review Pathways
Biologics Regulations
IND – Investigational New Drug
BLA- Biologics License Appli