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Brief report on the United States Food and Drug Administration Blood Products Advisory Committee recommendations for management of donors and units testing positive for hepatitis B virus DNA
Author(s) -
Lucey C.
Publication year - 2006
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1111/j.1423-0410.2006.00820.x
Subject(s) - food and drug administration , advisory committee , medicine , administration (probate law) , drug , virology , hepatitis b virus , virus , pharmacology , family medicine , political science , public administration , law
Background and Objectives This article briefly recounts the 21st July 2005, Blood Products Advisory Committee (BPAC) meeting concerning recommendations for management of donors and units testing positive for hepatitis B virus (HBV) DNA. Materials and Methods The author attended the meeting. The United States Food and Drug Administration (FDA) web site was used for meeting materials, and handouts were collected at the meeting to provide narrative information. Two European experts assisted with HBV subject matter. Results The proceedings of the advisory committee, the issue briefing materials, and testing algorithms are presented. Conclusion BPAC voted concurrence with the FDA algorithm for Management of Donors and Units Testing Positive for Hepatitis B Virus DNA.