FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website
horizonal rule
Dockets Management

Back


2005D-0261
BKG 1
Volume 1

Index

Tab 1 - Busch MP. Closing the windows on viral transmission by blood transfusion. In Stramer SL ed. Blood Safety in the New Millenium. Bethesda, MD: American Association of Blood Banks, 2001: Chapter 2, p.36. Published Material

Tab 2 - Glynn SA, Kleinman SH, Wright DJ, Busch MP. International application of the incidence rate/window period model. Transfusion 42:966-972 (2002). Published Material

Tab 3 - Dodd RY, Notari EP, Stramer SL. Current prevalence and incidence of infectious disease markers and, estimated window period risk in the American Red Cross blood donor population. Transfusion 42: 975-979 (2002). Published Material

Tab 4 - Fiebig EW, Wright DJ, Rawal BD, et. al. Dynamics of HIV-1 viremia and antibody seroconversion in plasma donors: Implications for diagnosis and staging of primary HIV-1 infection. AIDS 17:1871-1879 (2003). Published Material

Tab 5 - FDA Memorandum to All Registered Blood Establishmeats: "Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV-1) Transmission by Blood and Blood Products," April 23, 1992.

Tab 6 - FDA Memorandum to All Registered Blood and Plasma Establishments: "Recommendations for Donor Screening with a Licensed Test for HIV-l Antigen," August 8, 1995.

Tab 7 - FDA Memorandum to All Registered Blood Establishments: "Revised Recotnmendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)," August 5, 1993.

Tab 8 - Federal Register, 11/16/00 (65 FR 69378), Proposed Rule: Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection ("Lookback")

Tab 9 - Federal Register, 12/14/99 (64 FR 71147), Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2, December 1999.

Tab 10 - Blood Products Advisory Committee, 69th Meeting, June 14, 2001, http://www.fda.gov/ohrms/dockets/ac/cber01.htm Blood Products Advisory Committee. Part 2

Tab 11 - Alter HJ. To C or not to C: These are the questions, Blood 85:1681-1695 (1995). Published Material

Tab 12 - CDC, Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR 47, (RR-19) (1998).

Tab 13 - See 21 CFR 610.40(b) for licensed test kits or 21 CFR 601.20(a) for licensed in-house assays. Published Material, Part 2


Top | Back

Page last updated August 12, 2005 RSChorizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management