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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. Criteria for Exemption of Lot Release

    Criteria for Exemption of Lot Release

    89 downloads

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  2. Physician Substitutes (Update)

    Physician Substitutes (Update)

    81 downloads

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  3. 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

    50 downloads

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  4. Recommendations for Implementation of Computerization in Blood Establishments

    Recommendations for Implementation of Computerization in Blood Establishments

    77 downloads

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  5. Control of Unsuitable Blood and Blood Components

    Control of Unsuitable Blood and Blood Components

    55 downloads

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    0 comments

    Submitted

  6. HTLV-I Antibody Testing

    HTLV-I Antibody Testing

    86 downloads

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    0 comments

    Submitted

  7. Handling of Human Blood Source Materials

    Handling of Human Blood Source Materials

    84 downloads

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

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

    79 downloads

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  9. Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)

    Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)

    58 downloads

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

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

    86 downloads

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  11. Reduction of the Maximum Platelet Storage Period tp 5 Days in an Approved Container

    Reduction of the Maximum Platelet Storage Period tp 5 Days in an Approved Container

    85 downloads

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  12. Plasma Derived from Therapeutic Plasma Exchange

    Plasma Derived from Therapeutic Plasma Exchange

    71 downloads

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  13. 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)

    61 downloads

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  14. Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes)

    Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes)

    60 downloads

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