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Food and Drug Administration

Transmissible Spongiform Encephalopathies Advisory Committee

September 18-19, 2006

Slides

September 18, 2006

BSE: World Update, L. Ferguson, DVM, USDA (ppt) (htm)

Update: - vCJD Epidemiology and Transfusion-transmission, D. Scott, M.D., FDA (ppt) (htm)

Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980), A. Williams, Ph.D., FDA (ppt) (htm)

Critical Factors Iinfluencing Prion Decontamination Using Sodium Hydroxide – PPTA Collaborative Study, K. Cai, Ph.D, PPTA, Talecris Biotherapeutics (ppt) (htm)

TSE Clearance Studies for pdFVIII: Study Methods and Clearance Levels, D. Scott, M.D., FDA (ppt) (htm)

Industry TSE Clearance Studies for pdFVIII, T. Kreil, Ph.D., PPTA, Baxter Bioscience (ppt) (htm)

Update: Status of FDA’s Initiative on Communication of the Potential Exposure to vCJD Risk from an Investigational Product, Plasma Derived Factor XI that was Manufactured from UK Donor Plasma, M. Weinstein, Ph.D., FDA (ppt) (htm)

Summary of World Health Organization Consultation on Distribution of Iinfectivity in Tissues of Animals and Humans with Transmissible Spongiform Encephalopathies, D. Asher, M.D., FDA (ppt) (htm)

September 19, 2006

Potential Screening Assays to Detect Blood and Plasma Donors Infected with TSE Agents: Possible Criteria for Validation, P. Piccardo, MD, FDA (ppt) (htm)

Proposed Algorithm for Approval of Human TSE Tests in Europe, M. Turner, MBChB, PhD, FRCP, FRCPath, University of Edinburgh (ppt) (htm)

Objective: To define a process such that if an assay method successfully completes it, it is justifiable to try it in the Blood Transfusion Service at some scale. (ppt) (htm)

Development of Rapid Blood Screening Tests for vCJD, Alex Raeber, Prionics AG (ppt) (htm)

Use of PMCA for Biochemical Diagnosis of Prion Diseases, Claudio Soto, PhD, University of Texas Medical Branch and Aprion Inc. (ppt) (htm)

The Seprion Separation System: Development of a feasible blood screening protocol for abnormal prion protein, Stuart Wilson, Microsens Biotechnologies (ppt) (htm)

Detection of PrPres in Plasma, H. Perron, Biomerieux (ppt) (htm)

Pronucleon Amplified Misfolded Protein Diagnostic Assay (AMP-D) Kenton Lohman, Ph.D., Adlyfe Inc. (ppt) (htm)

CHIRON Submission, David Peretz, M.Sc., D.Sc. (ppt) (htm)

Open Public Hearing Speakers

List of Speakers for September 18-19, 2006 (pdf)

Committee of Ten Thousand (pdf)

Transmissible Spongiform Encephalopthy Advisory Committe, Charles Sims, MD, FDA (pdf)

The Case for Reconsidering the FDA Restriction on the Use of Cells and Tissues from Individuals Having Resided in Europe for 5 or More Years (pdf)

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