Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Tissue testing: FDA issues 1guidance on screening donors of cells, tissues and cell- and tissue-based products Feb. 28. The guidelines add three new diseases - West Nile Virus, vaccinia and sepsis - that facilities should test for to those included in a May 2004 draft version. The draft had been released in conjunction with a final donor eligibility rule developed by the agency's biologics center as part of a revamped tissue regulation framework (2"The Gray Sheet" May 24, 2004, p. 11). The new guidance also finalizes components of a 2002 draft guidance with recommendations on reducing the risk of Creutzfeldt-Jakob disease (the human version of "mad cow" disease). Further, it recommends nucleic acid amplification testing for HIV and hepatitis C in both living and cadaveric donors, rather than just the latter; modifies the agency's approach to identifying new "relevant" diseases; and adjusts procedures for communicable disease testing laboratories...