Jump to content
April 2024 Challenge

Cliff

The Help
 View Profile  See their activity

  • Posts

    3,508

  • Joined

  • Last visited

  • Days Won

    146

  • Country

    United States

 Content Type 

Files posted by Cliff

  1. More information about "Revised Guidelines for the Collection of Platelets, Pheresis"

    Revised Guidelines for the Collection of Platelets, Pheresis

    By Cliff in FDA Memorandum to Blood Establishments

    Revised Guidelines for the Collection of Platelets, Pheresis

    56 downloads

       (0 reviews)

    0 comments

    Submitted

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

    Criteria for Exemption of Lot Release

    By Cliff in FDA Memorandum to Blood Establishments

    Criteria for Exemption of Lot Release

    89 downloads

       (0 reviews)

    0 comments

    Submitted

  3. More information about "Physician Substitutes (Update)"

    Physician Substitutes (Update)

    By Cliff in FDA Memorandum to Blood Establishments

    Physician Substitutes (Update)

    81 downloads

       (0 reviews)

    0 comments

    Submitted

  4. 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 in FDA Memorandum to Blood Establishments

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

    50 downloads

       (0 reviews)

    0 comments

    Submitted

  5. More information about "Recommendations for Implementation of Computerization in Blood Establishments"

    Recommendations for Implementation of Computerization in Blood Establishments

    By Cliff in FDA Memorandum to Blood Establishments

    Recommendations for Implementation of Computerization in Blood Establishments

    77 downloads

       (0 reviews)

    0 comments

    Submitted

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

    Control of Unsuitable Blood and Blood Components

    By Cliff in FDA Memorandum to Blood Establishments

    Control of Unsuitable Blood and Blood Components

    55 downloads

       (0 reviews)

    0 comments

    Submitted

  7. More information about "HTLV-I Antibody Testing"

    HTLV-I Antibody Testing

    By Cliff in FDA Memorandum to Blood Establishments

    HTLV-I Antibody Testing

    86 downloads

       (0 reviews)

    0 comments

    Submitted

  8. More information about "Handling of Human Blood Source Materials"

    Handling of Human Blood Source Materials

    By Cliff in FDA Memorandum to Blood Establishments

    Handling of Human Blood Source Materials

    84 downloads

       (0 reviews)

    0 comments

    Submitted

  9. 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 in FDA Memorandum to Blood Establishments

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

    79 downloads

       (0 reviews)

    0 comments

    Submitted

  10. More information about "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)

    By Cliff in FDA Memorandum to Blood Establishments

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

    58 downloads

       (0 reviews)

    0 comments

    Submitted

  11. More information about "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)

    By Cliff in FDA Blood Guidances

    Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research These recommendations set forth a series of procedures by which an initially HBsAg reactive donor may be reevaluated by a blood establishment, providing that all other donor suitability requirements are met. The decision of whether an initially reactive donor is to be reevaluated is left to the blood establishment. 
    Furthermore, a blood establishment may adopt more stringent procedures, provided they are. consistent with these recommendations. At each step in this procedure, the predominance of each test and the interpretation of results should be as specified, in the package insert for that kit.
     

    0 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 in FDA Memorandum to Blood Establishments

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

    86 downloads

       (0 reviews)

    0 comments

    Submitted

  13. More information about "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

    By Cliff in FDA Memorandum to Blood Establishments

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

    85 downloads

       (0 reviews)

    0 comments

    Submitted

  14. More information about "Plasma Derived from Therapeutic Plasma Exchange"

    Plasma Derived from Therapeutic Plasma Exchange

    By Cliff in FDA Memorandum to Blood Establishments

    Plasma Derived from Therapeutic Plasma Exchange

    71 downloads

       (0 reviews)

    0 comments

    Submitted

  15. More information about "Plasma Derived from Therapeutic Plasma Exchange"

    Plasma Derived from Therapeutic Plasma Exchange

    By Cliff in FDA Blood Guidances

    Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research In an April 1, 1983, Notice published in the Federal Register (Vol. 48, No. 64, page 14048), the Food and Drug Administration (FDA) advised that plasma derived from therapeutic exchange procedures is a biological product subject to the licensing provisions of the Public Health Service Act [42 USC 262 (a)] then collected and shipped for further manufacture into in vitro diagnostic products.

    2 downloads

       (0 reviews)

    0 comments

    Submitted

  16. 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 in FDA Memorandum to Blood Establishments

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

    61 downloads

       (0 reviews)

    0 comments

    Submitted

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

    Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes)

    By Cliff in FDA Memorandum to Blood Establishments

    Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes)

    60 downloads

       (0 reviews)

    0 comments

    Submitted

×
×
  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.