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Documents Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biologics"

1. Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biologics" William R. Tolbert, Ph.D. AOAC-SCS Regulatory & Compliance Conference…

Documents GTPs vs. cGMPs

1. WR Tolbert & Associates Consultants to the Biopharmaceutical Industry 11483 Cypress Woods Drive San Diego, CA 92131-3535 858-693-8163 [email protected] / www.wrtolbert.com…

Documents 1 FDA Regulation of Cellular, Tissue, and Gene Therapies Celia M.Witten, Ph.D., M.D. Director,...

Slide 1 1 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…