Food and Drug Administration

Cellular, Tissue and Gene Therapies Advisory Committee

March 30, 2007

Slides

Sipuleucel-T

FDA

FDA Draft Guidance for Industry, Ellen Lazarus (ppt) (htm)

Open Public Hearing: Slides and Written Statements

Statement of AABB, Joseph Giglio, MS MT(ASCP), CSQE(ASQ)CQA (ppt) (htm)

Statement of AABB (written), AABB, (pdf)

The Cancer Risk Associated with Ethylene Oxide in the Processing of Cord Blood, Byron Butterworth, Ph.D., Butterworth Consulting, John Chapman, Ph.D., ThermoGenesis Corp. (ppt) (htm)

The Potential Risk Associated with the Use of Ethylene Oxide as a Sterilant for Cord Blood ProcessingSystems, Byron E. Butterworth, Ph.D., Fellow ATS, Consultant for ThermoGenesis Corp., John R. Chapman, Ph.D., ThermoGenesis Corp. (htm)

Regulation of Unrelated Cord Blood Banking Meeting the Needs of the U.S. Public, John Miller, MD, PhD, (ppt) (htm)

Regulation of PBSC and DLI from Unrelated Donors: Meeting the Needs of the U.S. Public, John Miller, MD, (ppt) (htm)

Summary Statement from the American Society for Blood and Marrow Transplantation, Robert Soiffer, (pdf)

Summary statement from the Foundation for the Accreditation of Cellular Therapy, Phyllis I. Warkentin, (htm)

FACT-NetCord International Standards & Accreditation, Foundation for the Accreditation of Cellular Therapy, Phyllis I. Warkentin, MD (ppt) (htm)

Testimony on Guidance Document for Licensing Cord Blood Banks, Elizabeth J. Shpall, MD, International NetCord Foundation 2007-4291oph2_7 (ppt) (htm)

Comments of International Society for Cellular Therapy (ISCT), Elizabeth Read, MD, FDA (ppt) (htm)

Bibliography (htm)

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