Joint Meeting Transmissible Spongiform Encephalopathies & Blood Products Advisory Committees January 17, 2001 Effectiveness of measures taken to protect humans from food-borne exposure to the BSE agent: Implications for risk of variant Creutzfeldt-Jakob disease and blood safety

2/19/02


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Joint Meeting Transmissible Spongiform Encephalopathies & Blood Products Advisory Committees January 17, 2001 Effectiveness of measures taken to protect humans from food-borne exposure to the BSE agent: Implications for risk of variant Creutzfeldt-Jakob disease and blood safety

Issue

Approaches to Remote or Theoretical Risks of Contamination in Regulated Products

History of FDA Guidances on Precautionary Measures to Reduce Possible Risk of Transmission of Creutzfeldt-Jakob Disease & Variant Creutzfeldt-Jakob Disease by Blood & Blood Products

History of FDA Guidances on CJD/vCJD regarding Blood and Blood Products

History of FDA Guidances on CJD/vCJD regarding Blood and Blood Products

FDA Revised Guidance on CJD/vCJD & Blood Jan 2002: Estimated Reduction in Risk-adjusted Donor Days after Implementation (A. Williams, OBRR, CBER, FDA)

18 Countries with BSE in Native Cattle [yr first reported & approx. total cases through 2001 per OIE Dec 2001]

Measures thought to be effective in protecting humans from food-borne exposures to BSE agent

Measures thought to be effective in protecting humans from food-borne exposures to BSE agent

Measures thought to be effective in protecting humans from food-borne exposures to BSE agent

Measures thought to be effective in protecting humans from food-borne exposures to the BSE agent

Measures thought to be effective in protecting humans from food-borne exposures to the BSE agent

Charge

Question 1

Question 2

Question 3

PPT Slide

Author: David M. Asher, MD