Food and Drug Administration

Cellular, Tissue and Gene Therapies Advisory Committee

March 29, 2007

 

Slides

Sponsor: Dendreon Corp.

Sipuleucel-T

Provenge® (sipuleucel-T), , Elizabeth Smith, Dendreon Corp. (pdf)

FDA

Sipuleucel-T
FDA Chemistry, Manufacturing and Controls Findings, Keith Wonnacott, PhD, Ke Liu, MD, PhD, BoGuang Zhen, PhD (ppt) (htm)

FDA Clinical Review and Findings, Ke Lie, MD, PhD (ppt) (htm)

FDA Statistical Review and Findings, Boguang Zhen, PhD (ppt) (htm)

FDA Overview of Activities, Raj Puri, M.D., Ph.D. (ppt) (htm)

FDA Site Visit November 3, 2006 , Steven R. Bauer, PhD, Deborah Hursh, PhD, Gerald Marti, MD, PhD, Brenton McCright, PhD, Malcolm Moos, PhD, MD, John Terrig Thomas (ppt) (htm)

Open Public Hearing: Written Statements

Prostate Health Education Network, Thomas Farrington (htm)

Statement in Support of Approving Provenge, Ed Grove (htm)

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