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FDA DHHS TSE ADVISORY COMMITTEE September 18 and 19 2006

flounder

Well-known member
Subject: FDA DHHS TSE ADVISORY COMMITTEE September 18 and 19 2006 ''There is a growing number of human CJD cases, Gambetti''
Date: November 4, 2006 at 7:41 pm PST

Meeting of:

TRANSMISSIBLE

SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE

September 18, 2006

Holiday Inn Gaithersburg

Gaithersburg,Maryland


TABLE OF CONTENTS

Page

Administrative Remarks - Executive Secretary 1

Opening Remarks, Glenn Telling 8

Committee Updates:

- US and Worldwide BSE 8

- vCJD epidemiology and transfusion transmission 26

- Draft Guidance for Industry: Amendment (donor 32

deferral for transfusion in France Since 1980)

- Critical Factors Influencing Prion 39

Decontamination Using Sodium Hydroxide

- Human Prions: Clearance and Plasma Lipoproteins 53

TOPIC I: Experimental Clearance of Transmissible

Spongiform Encephalopathy Infectivity on

Plasma Derived FVIII Products 69

TSE Clearance studies for pdFVIII: Study Methods and 70

Clearance Levels

Industry TSE Clearance Studies for pdFVIII 95

Open Public Hearing 116

- Statement by Dave Cavenaugh 118

Open Committee Discussion, Questions for the Committee 122

Committee Updates:

Status of FDA's Initiative on Communication of the 177

Potential Exposure to vCJD Risk

Summary of WHO Consultation on Distribution of 184

Infectivity in Tissues

Open Public Hearing 201

- Statement by Charles Sims 203

- Statement by Paul Brown 209


snip...



I went through the proceedings and I selected some points that I thought were of particular interest to this group today, and I list them on the next three or four slides:

Naturally affected cattle, infectivity detected by mouse assay demonstrated only in brain, spinal cord, retina and a pool of nictitating membranes, but not in pools of lymph nodes.

Infectivity was detected in some peripheral nerves, and a solitary muscle of a single case of BSE in a German cow. That is a greater concern in Europe where there is more BSE than the maximum of one case per million, we hope, that USDA estimates here. There was only infectivity found in a semi-tendonoisis muscle using only an extremely sensitive transgenic mouse that Martin Groship(?) has developed.

Still, it would be disturbing if meat itself was intrinsically infected rather than neural tissue, because

192



full text 223 pages ;




http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm




http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf






Meeting of:

TRANSMISSIBLE

SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE

September 19, 2006

Holiday Inn Gaithersburg

Gaithersburg, Maryland


TABLE OF CONTENTS

Page

Opening Remarks 1

Topic II: Possible Criteria for Approval of

a Donor Screening Test for vCJD

Donor Screening Test Issues: Sensitivity, Specificity 4

and Confirmatory Testing

Algorithm for Approval of Human TSE Tests in Europe 13

Available Reference Materials 35

Research Updates from Test Developers: 69

- Prionics - A. Raeber 70

- University of Texas - C. Soto 78

- Microsens Biotechnologies - S. Wilson 88

- BioMerieux - Dr. Van Driesische 94

- Adlyfe - K. Lohman 98

- Chiron - D. Peretz 109

- UC San Francisco - J. Safar 117

Questions for Presenters from Committee 128

Open Public Hearing 144

- Arllene Carr-Greer 145

Open Committee Discussion 148



http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t2.pdf




http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t2.htm




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