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Winter 1997-98 Volume 2, Number 4 |
Hepatitis C targeted lookback guidance issued On March 20, 1998, FDA promulgated "Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis Virus (Anti-HCV)." The document provides recommendations for compliance with FDA's new requirements for HCV targeted lookback (see HCR Fall 1997), including recommendations for the further testing of donors who are repeatedly reactive for antibody to HCV, quarantine of prior collections from such donors and notification of consignees, record-keeping, retrospective review of records of donor testing following the implementation of a licensed multi-antigen screening test for antibody to HCV, actions to be taken following indeterminate test results, actions to be taken for donors testing repeatedly reactive for antibody to HCV with no record of additional testing for HCV, and transfusion recipient notification and counseling by physicians. FDA has said that the document is being distributed for comment purposes and for implementation. It can be found at http://www.fda.gov/cber/guidelines.htm. |
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