| 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for comment, not for implementation).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Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)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) |
