Mad Cow Disease Transmission Risk For Medical Products To Be Discussed At Feb. 12-13 Meeting
Models of risk-based approaches for bovine material sourcing for medical products will be discussed by FDA’s Transmissible Spongiform Encephalopathies Advisory Committee on the first day of a Feb. 12-13 meeting.
Also on Feb. 12, the committee will receive an update on the case of bovine spongiform encephalopathy recently reported in a U.S. cow. The first case of mad cow disease in an animal in the U.S. was reported in Washington state in December 2003. The first Canadian case was reported in May.
The committee will also hear presentations on a presumptive transfusion transmitted case of variant Creutzfeldt-Jakob disease reported recently in the U.K. and hear updates on related experimental studies in animals on transmission of TSE agents by blood and relevant epidemiology of human TSEs.
A preliminary discussion of FDA’s current recommendations on measures to minimize risk from TSE agents in various medical products will take place on Feb. 13.
At a July 17, 2003 meeting, the committee said that FDA should clarify its recommendations to industry about safe sources of bovine bone gelatin for use in cosmetics, dietary supplements and drugs.
The committee voted seven to two, with one abstention, that available scientific data and information support FDA’s current guidance on bone gelatin.
However, the committee also felt the agency needs to define what "BSE-free herd" means and revise its description of when bovine spine should be removed after slaughter.
To watch a live or archived webcast of this meeting, click the button below. To arrange for live videoconferencing or to order videotapes & CDs, email
webcasthelp@elsevier.com or call 800-332-1370 ext. 7210.
Posted: Friday, January 09, 2004
http://www.fdaadvisorycommittee.com/...304MadCowA.htm
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