Topic 1: FDA Draft Guidance “Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products”

3/26/02


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Table of Contents

Topic 1: FDA Draft Guidance “Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products”

Previous Guidance- Deferrals

Post 1999 Guidance

TSEAC 6/28/2001

TSEAC 6/28/2001

FDA Draft Guidance: Donor Deferrals Phase I Implementation 5/31/02

U.K. Donor Deferral 1980- 1996 Food Chain Controls

PPT Slide

Non-European BSE

FDA Draft Guidance: Donor Deferrals Phase II Implementation 10/31/02

Source Plasma

Source Plasma

Effects of New Donor Deferrals Upon Supply of Blood/blood components

TSEAC Proposal Concerning Implementation of New Donor Deferrals, that “a national recruitment campaign and a system to monitor adequate blood supply,” be instituted

Current Efforts to Attenuate Effect of New Donor Deferrals on Blood Supply

Current Efforts to Attenuate Effect of New Donor Deferrals on Blood Supply

Draft Guidance - Future

TSEAC-Recommended Donor Deferrals – Risk Reduction

Author: Dorothy E. Scott