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Current 2008 Listing (listed in reverse chronological order)

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Date Posted Subject
July 3, 2008 Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion (FDA/CDRH)
July 2, 2008 Medical Device Notification (PSN-08-03) for 5.x and Addendum: Sunquest Laboratory Blood Bank and Blood Donor Modules (FDA/CBER)
June 26, 2008 Report: Trends in HIV/AIDS Diagnoses Among Men Who Have Sex with Men — 33 States, 2001-2006. MMWR Weekly. June 27, 2008 / 57(25);681-6.
June 25, 2008 Hausfater P et al. Cutaneous Infrared Thermometry for Detecting Febrile Patients. Emerg Infect Dis. 2008 Aug; [Epub ahead of print]
June 20, 2008 Lung injuries from transfusions have doctors stumped (Cleveland Plain Dealer)
June 19, 2008 2009 National Patient Safety Goals (Joint Commission)
June 12, 2008 Ahead of Print Article: Lockhart PB, et al. Bacteremia Associated With Toothbrushing and Dental Extraction. Circulation. 2008 Jun 9. [Epub ahead of print]
June 11, 2008 First Edition Paper: Higgins JM, Sloan SR. Stochastic modeling of human RBC alloimmunization: evidence for a distinct population of immunologic responders. Blood. Prepublished online June 5, 2008
June 11, 2008 FDA Medical Device Safety Tips & Articles: How Human Factors Lead to Medical Device Adverse Events (FDA/CDRH)
May 30, 2008 Public Workshop:Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) April 29-30, 2008 Transcripts (FDA/CBER)
May 30, 2008 Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff (FDA/CDRH)
May 30, 2008 Biological Product Deviation Reports: Annual Summary for Fiscal Year 2007 (FDA/CBER)
May 23, 2008 Draft Cellular Therapy ISBT 128 Document Posted for Comment: ICCBBA has posted a cellular therapy document for comment. The DRAFT United States Industry Consensus Standard for the Uniform Labeling of Cellular Therapy Products using ISBT 128, Version 1 Draft G is posted online for COMMENT through August 1, 2008. (Editors' Note: this is for comment, not for implementation).
May 23, 2008 FDA Launches Sentinel Initiative: a national, integrated, electronic system for monitoring medical product safety (FDA)
May 23, 2008 Blood Banks Target High School Donors (NPR)
May 21, 2008 Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc) (FDA/CBER)
May 21, 2008 Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays (FDA/CDRH)
May 21, 2008 First Edition Paper: Singleton BK, et al. Mutations in EKLF/KLF1 form the molecular basis of the rare blood group In(Lu) phenotype. Blood. Prepublished online May 16, 2008.
May 16, 2008 Bayer pulls Trasylol supplies after study (MSNBC) Also see full text NEJM article: Fergusson DA, et al. A Comparison of Aprotinin and Lysine Analogues in High-Risk Cardiac Surgery. 1: N Engl J Med. 2008 May 14. [Epub ahead of print]
May 16, 2008 Medical Device Recall: Thermogenesis BioArchive Vapor Bypass Assembly (FDA/CBER)
May 16, 2008 Product Approval Information: Novo Nordisk - NovoSevenRT Coagulation Factor VIIa (Recombinant) (FDA/CBER) Also see: FDA News Item
May 2, 2008 Federal Register Notice: Meeting of the Advisory Committee on Blood Safety and Availability on May 29-30, 2008. Of particular note: The Committee will be asked to discuss and make recommendations on reports of adverse outcomes associated with transfusion of older red cells
May 2, 2008 Viscosity Enhancers Curb Bleeding Complications: Loss of 40% or more of blood can be life-threatening (US News & World Report)
Apr. 26, 2008 FDA News: FDA Clears Glove Made from New Type of Latex
Apr. 25, 2008 Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (FDA/CBER)
Apr. 24, 2008 AABB Association Bulletin #08-03: West Nile Virus – Revised Recommendations for Triggering Individual Donation Nucleic Acid Testing and Use of Communication Plans (AABB membership required to access)
Apr. 22, 2008 Recall: Rho(D) Immune Globulin (Human) Hyper RHO S/D, Mini-Dose (FDA/CBER)
Apr. 22, 2008 Medical Device Notification (PSN-08-03): Sunquest Laboratory Blood Bank and Blood Donor Modules (FDA/CBER)
Apr. 22, 2008 Outbreak Notice: Reinstatement of Malaria Recommendations for Great Exuma, Bahamas (CDC)
Apr. 17, 2008 Product Safety Information: Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product (FDA/CBER)
Apr. 15, 2008 Product Approval Information: ARTISS [Fibrin Sealant (Human)] (FDA/CBER)
Apr. 15, 2008 Multiple simultaneous kidney transplants: Chicago Hospital Performs Rare, Four-Way Kidney Transplant (ABC News) AND Hopkins performs 1st U.S. '6-way' transplants: Kidney patients receive organs of donors in 'domino' swap (Baltimore Sun)
Apr. 9, 2008 Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (FDA/CBER)
Apr. 9, 2008 Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs) (FDA/CBER)
Apr. 8, 2008 First Edition Paper: Takayama N, et al. Generation of functional platelets from human embryonic stem cells in vitro via ES-sacs, VEGF-promoted structures that concentrate hematopoietic progenitors. Blood. Prepublished online April 3, 2008.
Apr. 8, 2008 Indiana Blood Center donations go high-tech (Indianapolis Star)
Apr. 5, 2008 Officials say organ recipients caught tuberculosis from donor (Houston Chronicle)
Mar. 28, 2008 Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis: list of establishments granted approval for a variance to 21CFR640.3(d) and 21CFR640.3(f) (FDA/CBER)
Mar. 28, 2008 DNA test as close as your local drugstore: home paternity kit now available (Pittsburg Post-Gazette)
Mar. 28, 2008 Manual of Standard Operating Procedures and Policies: Regulatory - Compliance: Procedures for Handling Adverse Reaction Reports Related to "361" Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), SOPP 8508, Version #2, Mar. 26, 2008 (FDA/CBER)
Mar. 22, 2008 Recall-Firm Press Release: B. Braun’s Supplier Recall of Heparin API Prompts Voluntary Recall of Heparin Solutions (FDA/CBER)
Mar. 22, 2008 Original Article: Koch CG, et al. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med. 2008 Mar 20; 358(12):1229-39.
Mar. 22, 2008 Product Approval Information: XYNTHA™ Antihemophilic Factor (Recombinant), Plasma/Albumin Free, Wyeth Pharmaceuticals, Inc (FDA/CBER)
Mar. 17, 2008 CAP Transfusion Medicine Topic Center New Items: RhIG Dose Calculator (Zip MS Excel File) and Disclaimer (MS Word File)
Mar. 17, 2008 Page Updated: Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays (FDA/CBER)
Mar. 14, 2008 F.D.A. Panel Votes to Continue Use of Anemia Drugs - but does vote for additional restrictions on the use of anemia drugs by cancer patients (New York Times)
Mar. 14, 2008 MedWatch Information: Amgen and FDA notify healthcare professionals of changes to the Boxed Warnings for increased mortality and/or tumor progression section of the Aranesp and Epogen/Procrit labeling (FDA/CDER)
Mar. 14, 2008 FDA Panel Favors Approval for Amgen's Nplate to Treat Blood-Clotting Disorder (Yahoo Finance)
Mar. 12, 2008 Immucor acquires BioArray Solutions (Atlanta Business Chronicle)
Mar. 9, 2008 Page Updated: Notification Process for Transfusion Related Fatalities and Donation Related Deaths (FDA/CBER)
Mar. 5, 2008 Important Safety Information: Dosing and Administration of Immune Globulin (Human), GamaSTAN™ S/D Packaged in 2-ml Syringes (FDA/CBER)
Mar. 4, 2008 Medical Device Notification: Haemonetics Filtered Red Cell Disposable Kits (FDA/CBER)
Feb. 29, 2008 Recall: Thymoglobulin. Genzyme Corporation (FDA/CBER)
Feb. 29, 2008 Updated: Organizational Information (FDA/CBER)
Feb. 22, 2008 Recall: ThermoGenesis AXP Bag Sets 8-5101 (FDA/CBER)
Feb. 22, 2008 Federal Register: Risk Communication Advisory Committee; Notice of Meeting (FDA, HHS)
Feb. 19, 2008 Survey: Patients harmed by anemia drug policy-but CMS is skeptical of the poll and is sticking by its Medicare coverage decision (AMA News)
Feb. 13, 2008 FDA News: Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions Also see Baxter Updated News Release and Problems With Baxter Heparin Still Unresolved (Medscape) and Blood-drug supply may thin (Chicago Tribune, free registration required)
Feb. 13, 2008 CLSI (formerly NCCLS) Publishes Guideline for the Collection, Transport, and Processing of Blood Specimens for Coagulation Assays (Centredaily)
Feb. 13, 2008 Clinical Trials & Observations: The prognostic significance of a positive direct antiglobulin test in chronic lymphocytic leukemia: a beneficial effect of the combination of fludarabine and cyclophosphamide on the incidence of hemolytic anemia. Blood, 15 February 2008, Vol. 111, No. 4, pp. 1820-1826.
Feb. 10, 2008 Article: Webert KE, et al. Proceedings of a consensus conference: pathogen inactivation-making decisions about new technologies. Transfus Med Rev. 2008 Jan;22(1):1-34.
Feb. 10, 2008 Federal Register: Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Confirmation of Effective Date and Technical Amendment (FDA/CBER)
Feb. 10, 2008 First Edition Paper: Goerge T, et al. Inflammation induces hemorrhage in thrombocytopenia. Blood. Prepublished online February 6, 2008; DOI 10.1182/blood-2007-11-123620.
Feb. 10, 2008 Early Release: Acute Allergic-Type Reactions Among Patients Undergoing Hemodialysis - Multiple States, 2007-2008. MMWR. February 1, 2008 / 57 (Early Release);1-2.
Feb. 6, 2008 Article: Leiss W, et al. Men having sex with men donor deferral risk assessment: an analysis using risk management principles. Transfus Med Rev. 2008 Jan;22(1):35-57.
Feb. 6, 2008 SJ State's blood drive ban called misguided: Officials incensed at San Jose State's decision, say supplies threatened (San Mateo County Times)
Feb. 6, 2008 Revised OPTN/UNOS Policies for Organ Donor Testing and Allocation (OPTN)
Feb. 1, 2008 Press Release: Gambro BCT and Fenwal Suspend PASSPORT Post-Market Surveillance Study for 7-Day Platelets (Gambro BCT) Also see: Letter from AABB Bacterial Contamination Standard Task Force to Gambro BCT and Fenwal in Response to the Discontinuation of the Passport Study - 1/31/08 (AABB)
Jan. 30, 2008 ASH 50th Anniversary Review: Kaushansky K. Historical review: megakaryopoiesis and thrombopoiesis. Blood, 1 February 2008, Vol. 111, No. 3, pp. 981-986.
Jan. 28, 2008 FDA News: FDA Warns Public of Contaminated Syringes
Jan. 26, 2008 California Paul Gann Blood Safety Act amended
Jan. 26, 2008 Potential 2009 Joint Commission National Patient Safety Goal (NPSG) Requirements and Implementation Expectations Posted for Comment
Jan. 19, 2008 Product Recall: Baxter Healthcare Heparin Sodium Injection 1000 units/mL 10mL and 30mL Vials (FDA/MedWatch)
Jan. 18, 2008 Product Approval Information- Licensing Action: Abbott PRISM® HTLV-I/HTLV-II (FDA/CBER)
Jan. 17, 2008 Article: McCullough J. Pathogen Inactivation: A New Paradigm for Preventing Transfusion-Transmitted Infections. Am J Clin Pathol. 2007 Dec;128(6):945-55.
Jan. 12, 2008 Federal Register: Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Extension of Comment Period; Proposed Rule.
Jan. 1, 2008 2008 Tentative Blood Products Advisory Committee Meeting Schedule (FDA/CBER)

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