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Zdrowie i gospodarka · 31.01.2002

Draft “Guidance for Industry: Use of Nucleic Acid Tests on Pooled Samples From Source Plasma Donors to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV”; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Use of Nucleic Acid Tests on Pooled Samples From Source Plasma Donors to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV" dated December 2001. The draft guidance document, when finalized, would inform all establishments that manufacture Source Plasma that FDA has approved nucleic acid tests (NAT) to identify human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) in Source Plasma donations. The draft document recommends that manufacturers submit a prior approval supplement to a biologics license application (BLA) to implement HIV-1 and HCV NAT by a specified date.

Source: Federal Register — Food and Drug AdministrationOpen original release →