FDA Oversight of Cell Therapy Clinical Trials

Author:

Au Patrick1,Hursh Deborah A.1,Lim Agnes1,Moos Malcolm C.1,Oh Steven S.1,Schneider Bruce S.1,Witten Celia M.1

Affiliation:

1. Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD 20852, USA.

Abstract

U.S. Food and Drug Administration applies regulatory flexibility to balance benefits and risks to subjects in cell-therapy clinical trials.

Publisher

American Association for the Advancement of Science (AAAS)

Subject

General Medicine

Reference10 articles.

1. Making your voice heard at FDA;http://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm.

2. Cellular and gene therapy guidance documents;http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/default.htm.

3. Regulation of Somatic-Cell Therapy and Gene Therapy by the Food and Drug Administration

4. Donors of living cells U.S. Code title 21 section 1271 subpart C; http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271.

5. FDA guidance for industry: Source animal product preclinical and clinical issues concerning the use of xenotransplantation products in humans;http://www.fda.gov/BiologicsBloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/Xenotransplantation/ucm074354.htm.

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