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May 2024 Challenge

FDA Memorandum to Blood Establishments

Blood memoranda have not been issued since January 1997. This information is now being issued as guidance documents.

64 files

  1. More information about "Abbott Laboratories' HIVAG-1 test for HIV-1 antigen(s) not recommended for use as a donor screen"

    Abbott Laboratories' HIVAG-1 test for HIV-1 antigen(s) not recommended for use as a donor screen

    By Cliff

    Abbott Laboratories' HIVAG-1 test for HIV-1 antigen(s) not recommended for use as a donor screen

    72 downloads

       (0 reviews)

    0 comments

    Submitted

  2. More information about "Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-1) Release Panel"

    Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-1) Release Panel

    By Cliff

    Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-1) Release Panel

    70 downloads

       (0 reviews)

    0 comments

    Submitted

  3. More information about "Autologous Blood Collection and Processing Procedures"

    Autologous Blood Collection and Processing Procedures

    By Cliff

    Autologous Blood Collection and Processing Procedures

    91 downloads

       (0 reviews)

    0 comments

    Submitted

  4. More information about "Change in Equipment for Processing Blood Donor Samples"

    Change in Equipment for Processing Blood Donor Samples

    By Cliff

    Change in Equipment for Processing Blood Donor Samples

    73 downloads

       (0 reviews)

    0 comments

    Submitted

  5. More information about "Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing"

    Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing

    By Cliff

    Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing

    71 downloads

       (0 reviews)

    0 comments

    Submitted

  6. 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

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

    93 downloads

       (0 reviews)

    0 comments

    Submitted

  7. More information about "Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes)"

    Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes)

    By Cliff

    Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes)

    60 downloads

       (0 reviews)

    0 comments

    Submitted

  8. More information about "Control of Unsuitable Blood and Blood Components"

    Control of Unsuitable Blood and Blood Components

    By Cliff

    Control of Unsuitable Blood and Blood Components

    55 downloads

       (0 reviews)

    0 comments

    Submitted

  9. More information about "Criteria for Exemption of Lot Release"

    Criteria for Exemption of Lot Release

    By Cliff

    Criteria for Exemption of Lot Release

    89 downloads

       (0 reviews)

    0 comments

    Submitted

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

    Deferral of Blood and Plasma Donors Based on Medications

    By Cliff

    Deferral of Blood and Plasma Donors Based on Medications

    79 downloads

       (0 reviews)

    0 comments

    Submitted

  11. More information about "Deferral of Blood Donors Who Have Received the Drug Accutane (isotretinoin / Roche; 13-cis-retinoic acid)"

    Deferral of Blood Donors Who Have Received the Drug Accutane (isotretinoin / Roche; 13-cis-retinoic acid)

    By Cliff

    Deferral of Blood Donors Who Have Received the Drug Accutane (isotretinoin / Roche; 13-cis-retinoic acid)

    61 downloads

       (0 reviews)

    0 comments

    Submitted

  12. More information about "Deferral of Donors Who Have Received Human Pituitary-Derived Growth Hormone"

    Deferral of Donors Who Have Received Human Pituitary-Derived Growth Hormone

    By Cliff

    Deferral of Donors Who Have Received Human Pituitary-Derived Growth Hormone

    86 downloads

       (0 reviews)

    0 comments

    Submitted

  13. More information about "Deficiencies Relating to the Manufacture of Blood and Blood Components"

    Deficiencies Relating to the Manufacture of Blood and Blood Components

    By Cliff

    Deficiencies Relating to the Manufacture of Blood and Blood Components

    69 downloads

       (0 reviews)

    0 comments

    Submitted

  14. More information about "Discontinuance of Pre-Licensing Inspection for Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies Vaccines"

    Discontinuance of Pre-Licensing Inspection for Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies Vaccines

    By Cliff

    Discontinuance of Pre-Licensing Inspection for Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies Vaccines

    50 downloads

       (0 reviews)

    0 comments

    Submitted

  15. More information about "Disposition of Blood Products Intended for Autologous use that Test Repeatedly Reactive for Anti-HCV"

    Disposition of Blood Products Intended for Autologous use that Test Repeatedly Reactive for Anti-HCV

    By Cliff

    Disposition of Blood Products Intended for Autologous use that Test Repeatedly Reactive for Anti-HCV

    77 downloads

       (0 reviews)

    0 comments

    Submitted

  16. 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

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

    68 downloads

       (0 reviews)

    0 comments

    Submitted

  17. 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

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

    83 downloads

       (0 reviews)

    0 comments

    Submitted

  18. More information about "Draft Document Concerning the Regulation of Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products"

    Draft Document Concerning the Regulation of Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products

    By Cliff

    Draft Document Concerning the Regulation of Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products

    71 downloads

       (0 reviews)

    0 comments

    Submitted

  19. 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

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

    59 downloads

       (0 reviews)

    0 comments

    Submitted

  20. 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

    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

       (0 reviews)

    0 comments

    Submitted

  21. More information about "Eight-Hour Hold; Blood and Plasma Inspectors"

    Eight-Hour Hold; Blood and Plasma Inspectors

    By Cliff

    Eight-Hour Hold; Blood and Plasma Inspectors

    86 downloads

       (0 reviews)

    0 comments

    Submitted

  22. More information about "Exemptions to Permit Persons with a History of Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma: Alternative Procedures"

    Exemptions to Permit Persons with a History of Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma: Alternative Procedures

    By Cliff

    Exemptions to Permit Persons with a History of Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma: Alternative Procedures

    72 downloads

       (0 reviews)

    0 comments

    Submitted

  23. More information about "Extension of Dating Period For Storage of Red Blood Cells, Frozen"

    Extension of Dating Period For Storage of Red Blood Cells, Frozen

    By Cliff

    Extension of Dating Period For Storage of Red Blood Cells, Frozen

    79 downloads

       (0 reviews)

    0 comments

    Submitted

  24. More information about "FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)"

    FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)

    By Cliff

    FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)

    65 downloads

       (0 reviews)

    0 comments

    Submitted

  25. More information about "FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia Enterocolitica"

    FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia Enterocolitica

    By Cliff

    FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia Enterocolitica

    75 downloads

       (0 reviews)

    0 comments

    Submitted

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