FDA细胞治疗临床试验监督__培训课件.ppt

* * * * The NTTAA and OMB circular directs agencies to use voluntary consensus standards in lieu of government-unique standards except where inconsistent with law or otherwise impractical. The use of standards is outline in the Staff Manual Guide. Standards can be incorporated in regulation and guidance according to Code of Federal regulations. * FDA involvement in standards development activities is beneficial to the agency not only in that it provides a mechanism to ensure that standards developed do not conflict with FDA regulations but also support the production of guidance documents by FDA. * FDA Oversight of Cell Therapy Clinical Trials Celia Witten, Ph.D., M.D. Office Director, Office of Cellular, Tissue, and Gene Therapies CBER/FDA ISSCR/CIRM/ISCT Workshop June 15, 2010 San Francisco, California * FDA Organization Office of the Commissioner Office of Combination Products CBER (Center for Biologics Evaluation and Research): vaccines, 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 * OCTGT Products Cellular therapies Tumor vaccines and immunotherapy Gene therapies Tissue and tissue based products Xenotransplantation products Combination products Devices used for cells/tissues Donor screening tests (for use with cadaveric blood samples) * The “Tissue Rules”(21 CFR 1271, Effective May 25, 2005) Tissue Rule Issues Addressed Establishment Registration and Listing Applicability: types and uses of products that will be regulated by these rules; requirements for registering and listing products Donor Eligibility Requirements for donor screening and testing for “relevant communicable disease agents and diseases” Current Good Ti