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Cliff

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Files posted by Cliff

  1. More information about "Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis"

    Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis

    By Cliff in FDA Blood Guidances

    Docket Number: FDA-2022-D-0500 Issued by: Center for Biologics Evaluation and Research This memorandum addresses the temporary deferral of Source Plasma donors who have lost red blood cells due to technical difficulties during an automated plasmapheresis procedure.

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  2. More information about "Draft Document Concerning the Regulation of Placental/Umbilical Cord Blood Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products"

    Draft Document Concerning the Regulation of Placental/Umbilical Cord Blood Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products

    By Cliff in FDA Memorandum to Blood Establishments

    Draft Document Concerning the Regulation of Placental/Umbilical Cord Blood Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products

    59 downloads

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  3. More information about "Memorandum to All Registered Blood Establishments - Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen"

    Memorandum to All Registered Blood Establishments - Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to All Registered Blood Establishments - Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen

    55 downloads

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  4. More information about "Memorandum to All Registered Blood Establishments - Recommendations for Labeling and Use of Units of Whole Blood, Blood Components, Source Plasma, Recovered Plasma or Source Leukocytes Obtained from Donors with Elevated Levels of Alanine Aminotransferase"

    Memorandum to All Registered Blood Establishments - Recommendations for Labeling and Use of Units of Whole Blood, Blood Components, Source Plasma, Recovered Plasma or Source Leukocytes Obtained from Donors with Elevated Levels of Alanine Aminotransferase

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to All Registered Blood Establishments - Recommendations for Labeling and Use of Units of Whole Blood, Blood Components, Source Plasma, Recovered Plasma or Source Leukocytes Obtained from Donors with Elevated Levels of Alanine Aminotransferase (ALT)

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  5. More information about "Memorandum to All Registered Blood Establishments - Recommendations for the Deferral of Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes, and Source Plasma"

    Memorandum to All Registered Blood Establishments - Recommendations for the Deferral of Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes, and Source Plasma

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to All Registered Blood Establishments - Recommendations for the Deferral of Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes, and Source Plasma

    53 downloads

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  6. More information about "Memorandum to Licensed Establishments Performing Red Blood Cell Immunizations, Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors"

    Memorandum to Licensed Establishments Performing Red Blood Cell Immunizations, Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Licensed Establishments Performing Red Blood Cell Immunizations, Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors

    67 downloads

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  7. More information about "Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors"

    Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors

    By Cliff in FDA Blood Guidances

    Docket Number: FDA-2013-S-0611 Issued by: Center for Biologics Evaluation and Research On August 14, 1974, the Food and Drug Administration (FDA) issued a guideline recommending immunization schedules for Source Plasma donors participating in red blood cell immunization programs. FDA revised the guideline in June, 1980, with additional recommendations concerning red blood cell donor criteria, volume and frequency of collections, laboratory tests, preparation of antigen, and record keeping.
    Subsequently, the Center for ·Biologics Evaluation and Research (CBER) , FDA, issued a memorandum on October 7, 1988, entitled "Recommendations for Changeover from Use of Fresh Immunizing Red Blood Cells to Use of Frozen Immunizing Cells Stored a Minimum of Six Months Prior to Use" . This memorandum recommended the use of immunizing red blood cells stored for a minimum of six months prior to use to permit re-testing of red blood cell donors for infectious diseases, including anti-HIV, HBsAg, anti-HBc, and alanine aminotransferase (ALT) testing.

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  8. More information about "Memorandum to Registered Blood and Source Plasma Establishments, Revision of FDA Memorandum of August 27,1982: Requirements for Infrequent Plasmapheresis Donors"

    Memorandum to Registered Blood and Source Plasma Establishments, Revision of FDA Memorandum of August 27,1982: Requirements for Infrequent Plasmapheresis Donors

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Registered Blood and Source Plasma Establishments, Revision of FDA Memorandum of August 27,1982: Requirements for Infrequent Plasmapheresis Donors

    56 downloads

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  9. More information about "Memorandum to Registered Blood Establishments, Timeframe for Licensing Irradiated Blood Products"

    Memorandum to Registered Blood Establishments, Timeframe for Licensing Irradiated Blood Products

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Registered Blood Establishments, Timeframe for Licensing Irradiated Blood Products

    65 downloads

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  10. More information about "Memorandum to Registered Blood Establishments, Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems"

    Memorandum to Registered Blood Establishments, Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Registered Blood Establishments, Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems

    68 downloads

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  11. More information about "Draft Recommendation for the Quarantine and Disposition of Potentially HBV, HCV or HTLV-1 Contaminated Units from Prior Collections from Repeat Donors with Repeatedly Reactive Screening Tests. (Intended for discussion at the meeting of the BPAC on 12/15/9"

    Draft Recommendation for the Quarantine and Disposition of Potentially HBV, HCV or HTLV-1 Contaminated Units from Prior Collections from Repeat Donors with Repeatedly Reactive Screening Tests. (Intended for discussion at the meeting of the BPAC on 12/15/9

    By Cliff in FDA Memorandum to Blood Establishments

    Draft Recommendation for the Quarantine and Disposition of Potentially HBV, HCV or HTLV-1 Contaminated Units from Prior Collections from Repeat Donors with Repeatedly Reactive Screening Tests. (Intended for discussion at the meeting of the BPAC on 12/15/94)

    105 downloads

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  12. More information about "Memorandum to Registered Blood Establishments - Use of an FDA Cleared or Approved Sterile Connecting Device (STCD) in Blood Bank Practices"

    Memorandum to Registered Blood Establishments - Use of an FDA Cleared or Approved Sterile Connecting Device (STCD) in Blood Bank Practices

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Registered Blood Establishments - Use of an FDA Cleared or Approved Sterile Connecting Device (STCD) in Blood Bank Practices

    98 downloads

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  13. More information about "Memorandum to Registered Blood Establishments- Recommendations for Deferral of Donors for Malaria Risk"

    Memorandum to Registered Blood Establishments- Recommendations for Deferral of Donors for Malaria Risk

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Registered Blood Establishments- Recommendations for Deferral of Donors for Malaria Risk

    90 downloads

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  14. More information about "Recipient Serum Samples"

    Recipient Serum Samples

    By Cliff in FDA Memorandum to Blood Establishments

    Recipient Serum Samples

    65 downloads

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  15. More information about "Software Used in Blood Establishments"

    Software Used in Blood Establishments

    By Cliff in FDA Memorandum to Blood Establishments

    Software Used in Blood Establishments

    60 downloads

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  16. More information about "Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis"

    Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis

    By Cliff in FDA Memorandum to Blood Establishments

    Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis

    83 downloads

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  17. More information about "Memorandum to Registered Blood Establishments - Guidance Regarding Post Donation Information Reports"

    Memorandum to Registered Blood Establishments - Guidance Regarding Post Donation Information Reports

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Registered Blood Establishments - Guidance Regarding Post Donation Information Reports

    92 downloads

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  18. More information about "Clarification of the Use of Unlicensed Anti-HCV Supplemental Test Results in Regard to Donor Notification"

    Clarification of the Use of Unlicensed Anti-HCV Supplemental Test Results in Regard to Donor Notification

    By Cliff in FDA Memorandum to Blood Establishments

    Clarification of the Use of Unlicensed Anti-HCV Supplemental Test Results in Regard to Donor Notification

    93 downloads

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  19. More information about "Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)"

    Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)

    By Cliff in FDA Memorandum to Blood Establishments

    Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)

    85 downloads

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  20. More information about "Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)"

    Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)

    By Cliff in FDA Blood Guidances

    Docket Number: FDA-2013-S-0612 Issued by: Center for Biologics Evaluation and Research This memorandum transmits Revised Recommendations for Testing for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) in Blood Establishments, August, 1993. These revised recommendations modify those issued on April 23, 1992, in regard to testing for anti-HCV. A donor who currently tests, or who in the past had tested, repeatedly reactive for anti-HCV with a solid phase enzyme linked immunoassay (ELISA), licensed by the Food and Drug Administration (FDA), may now be considered for re-entry provided that certain criteria, described in this document, are fulfilled.

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  21. More information about "Deferral of Blood and Plasma Donors Based on Medications"

    Deferral of Blood and Plasma Donors Based on Medications

    By Cliff in FDA Memorandum to Blood Establishments

    Deferral of Blood and Plasma Donors Based on Medications

    79 downloads

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  22. More information about "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products"

    Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products

    By Cliff in FDA Memorandum to Blood Establishments

    Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products

    48 downloads

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  23. More information about "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products"

    Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products

    By Cliff in FDA Blood Guidances

    Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research This memorandum transmits recommendations regarding license amendments and procedures pertinent to irradiated blood and blood products. Irradiation of these products is a practice which has developed over many years to reduce the risk of transfusion-­associated graft-versus-host disease in recipients at this complication.
    Since labeling of blood and blood products as irradiated pertains to safety and intended use, irradiated and non-irradiated products are considered different products by the Center for Biologics Evaluation and Research. Recommendations are provided here regarding manufacturing and quality control procedures, labeling and other aspects of production and use of irradiated blood and blood products.

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  24. More information about "Revision of October 7, 1988 Memorandum Concerning Red Blood Cell Immunization Programs"

    Revision of October 7, 1988 Memorandum Concerning Red Blood Cell Immunization Programs

    By Cliff in FDA Memorandum to Blood Establishments

    Revision of October 7, 1988 Memorandum Concerning Red Blood Cell Immunization Programs

    75 downloads

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  25. More information about "Volume Limits for Automated Collection of Source Plasma"

    Volume Limits for Automated Collection of Source Plasma

    By Cliff in FDA Memorandum to Blood Establishments

    Volume Limits for Automated Collection of Source Plasma

    73 downloads

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