Transmissible Spongiform Encephalopathies Advisory Committee > October 28, 2010: Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript

October 28, 2010: Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript
October 28, 2010



The Holiday Inn Gaithersburg
2 Montgomery Village Avenue
Gaithersburg, Maryland


This transcript has not been edited or corrected, but appears as received from the commercial transcription service. Accordingly, the Food and Drug Administration makes no representation as to its accuracy.

Proceedings by:

CASET Associates, Ltd.
Fairfax, Virginia 22030
caset@caset.net


TABLE OF CONTENTS

Opening Remarks, Chair, TSEAC 1
Statement of Conflicts of Interest 3

Topic I: Review of FDA's Risk Assessment for Potential
Exposure to Variant Creutzfeldt-Jakob Disease in U.S.
Licensed Plasma-Derived Factor VIII
Introduction: Steven Anderson 7
Presentation of FDA Risk Assessment: Hong Yang 27
Summary and Questions for the Committee: Steven Anderson 50
Open Public Hearing 52
Open Committee Discussion 55

Topic II: Labeling of Plasma-Derived Products Including
Plasma-Derived Albumin and Products Containing Plasma-
Derived Albumin to Address the Possible Risk of Transmission
of Variant Creutzfeldt-Jakob Disease
Introduction and Rationale for Proposed Labeling Change for
Plasma Derivatives to Reflect vCJD Risk: Dorothy Scott 79
TSE Clearance in Manufacturing of Plasma Derivatives
Albrecht Groener 95
Summary and Questions for the Committee: Dorothy Scott 114
Open Public Hearing 112
Open Committee Discussion

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Transmissible Spongiform Encephalopathies Advisory Committee > October 28, 2010: Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript