AGENDA ITEMS - DAY 2 |
| Should the FDA take measures to insure that sheep and goats originating from or residing in high risk countries where BSE occurs are safe sources of materials for the manufacture of FDA regulated products? (14 x yes = unanimous) |
| Should the FDA take measures to insure that sheep and goats originating from or residing in high risk countries where Scrapie occurs are safe sources of materials for the manufacture of FDA regulated products? (14 x yes = unanimous) |
| Meeting Details |
| Attendees |
| Dr Freas |
| Proceedings |
| Dr Brown |
| Introduction |
| Dr. Charles Durfor, Ph.D. Center for Devices and Radiological Health in the FDA |
| Status of revising the
guidance for the preparation of a pre-market notification application for processed human dura mater |
| Dr David Asher, M.D. Center for Biologics Evaluation and Research of the FDA |
| Safe sourcing of materials from sheep and goats in countries not free of ruminant TSEs |
| Professor Almond, Ph.D. Pasteur-Marieux Connaught |
| The Potential Risk of Introducing BSE Agent into Sheep and Goats in Europe |
| Dr Richard Race, C.V.M. Rocky Mountain Laboratory |
| Infectivity in sheep tissues |
| Dr. Diane Sutton, D.V.M. USDA |
| Potential for Human and Animal Exposures to Animal TSE Agents in the USA |
| Dr, John Honstead, D.V.M. FDA |
| The briefest summary of the FDA regulation that's ever been given in history |
| Dr Lisa Ferguson, D.V.M. USDA |
| Measures for
consideration in assuring scrapie free sources of sheep and goat derived materials |
| Dr Kiki B Hellman, Ph.D. Center for Diseases and Radiological Health in the FDA |
| Committee charge and presentation of questions, |
| All Participants |
| Discussion |