FDAOversightofCellTherapyClinicalTrialsFDA细胞治疗的临床试验监督.pptVIP

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) 21 CFR Part 1271 These three rules form the platform for regulation of all human cells, tissues, and cellular and tissue-based products (HCT/Ps) For certain HCT/Ps (“361 HCT/Ps”), these regulations comprise the sole regulatory requirements For HCT/Ps regulated as drugs, devices, and/or biological products, the new tissue regulations supplement other requirements (GMP, QSR) Stem Cell-Based Products Fit regulatory definitions of the following: Human cells, tissues, or cellular and tissue based products (HCT/P) (21 CFR 1271.3(d)) Biologics (PHS Act) Drugs (FDC Act) Cell therapy Gene therapy- when genetic material is transferred to cells ex vivo Evolution of Stem Cell Field Cell therapy and gene therapy products –and therefore stem cell products-- do not lend themselves to a “one size fits all” concept of product development and regulation Regulations set framework of criteria that must be fulfilled: safety, identity, purity, pot