| Date Posted |
Subject |
| Dec. 28, 2011 |
Early View Article: Wang D, et al.Transfusion of older stored blood and risk of death: a meta-analysis. Transfusion. Article first published online: 21 Dec 2011 DOI: 10.1111/j.1537-2995.2011.03466.x |
| Dec. 4, 2011 |
Public Workshop Transcript: Quarantine Release Errors in Blood Establishments (FDA/CBER) Also see posting on Nov. 5 below for meeting presentations. |
| Nov. 30, 2011 |
Public Workshop Transcripts - Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors (FDA/CBER) |
| Nov. 29, 2011 |
Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus (FDA/CBER) |
| Nov. 27, 2011 |
Direct Recall Classification Program (Blood and Plasma) (FDA/CBER) |
| Nov. 27, 2011 |
Interactive Guide to Laboratory Software and Instrumentation: Blood bank information systems, October 2011 (CAP Today) |
| Nov. 5, 2011 |
Recall of Blood Component Infusion Set (Product Code: 4C2223) Fenwal, Inc. (FDA/CBER) |
| Nov. 5, 2011 |
FDA Items of Interest:
• Public Workshop: Quarantine Release Errors in Blood Establishments Sept 13, 2011 Presentation
• Meeting Transcripts: Advisory Committee on Cellular, Tissue and Gene Therapies- Sept 22, 2011 | Sept 23, 2011 |
| Oct. 28, 2011 |
CDC Recommends Malaria Chemoprophylaxis for Travelers to Laconia District of Greece (AABB Standard Requires Donor Deferral) |
| Oct. 28, 2011 |
Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components and AABB Abbreviated Donor History Questionnaire Documents (FDA/CBER) |
| Oct. 21, 2011 |
Mendoza R, et al. Delayed Hemolytic Transfusion Reaction Without Detectable Autoantibodies or Alloantibodies: A Possible Role of Phosphatidylserine Exposure on Donor RBCs. LabMedicine. 2011 Oct;42(11):653-56. |
| Oct. 12, 2011 |
Clinical Crossroads: Readers Respond. Tess, Anjala. A 68-Year-Old Woman Contemplating Autologous Blood Donation Before Elective Surgery. JAMA, Published online October 11, 2011. The discussion of this Clinical Crossroads case, authored by Lynne Uhl, MD, will be published in the November 2, 2011, issue of JAMA; responses must be received by October 30, 2011, to be considered for online posting. |
| Oct. 11, 2011 |
Pro/Con: Two views of U.S. prohibiting gay men's blood donation (LA Times) |
| Sept. 23, 2011 |
AABB Association Bulletin: #11-02 - Final Interim Standard for Standards for Relationship Testing Laboratories, 9th edition (AABB Membership required to access) |
| July 19, 2011 |
April 28-29, 2011: Blood Products Advisory Committee Meeting Transcripts (FDA) |
| July 19, 2011 |
Safer blood transfusions: Researchers discover why stored blood becomes less safe as it ages (Wake Forest News Center) Also see Original Article: Donadee et al. Nitric Oxide Scavenging by Red Blood Cell Microparticles and Cell-Free Hemoglobin as a Mechanism for the Red Cell Storage Lesion. Circulation. 2011;published online before print July 11 2011, doi:10.1161/CIRCULATIONAHA.110.008698 |
| July 11, 2011 |
HemaCare Sells Red Blood Cell Collection Operation Assets to and Enters into a Multi-Year Platelet Supply Agreement with the American Red Cross (Yahoo News) |
| June 2, 2011 |
Guidance for Industry - Donors of Blood and Blood Components: Notification of Donor Deferral - Small Entity Compliance Guide (FDA/CBER) |
| June 2, 2011 |
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle (FDA/CBER) |
| May 24, 2011 |
Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2010 (FDA/CBER) |
| May 3, 2011 |
Guidance for Industry: "Computer Crossmatch" (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type) (FDA/CBER) |
| April 14, 2011 |
April 28-29, 2011: Blood Products Advisory Committee Meeting Document: Topic I: Testing Source Plasma for Hepatitis B Virus by Nucleic Acid Testing (PDF, FDA BPAC) |
| Mar. 21, 2011 |
Compliance Program Guidance Manual: 7342.002 - Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors (FDA/CBER) |
| Mar. 21, 2011 |
April 28-29, 2011: Blood Products Advisory Committee Meeting Announcement (FDA) |
| Mar. 17, 2011 |
Device Approval: OraQuick HCV Rapid Antibody Test - P080027/S001(FDA) |
| Mar. 17, 2011 |
Important Safety Information: Risk of Thrombotic Adverse Events with Subcutaneous or Inappropriate Intravenous Use of Vivaglobin (Immune Globulin Subcutaneous) (FDA/CBER) |
| Mar. 7, 2011 |
Terumo of Japan Agrees to Acquire Caridian From Gambro for $2.63 Billion (Bloomberg) |
| Mar. 6, 2011 |
Biological Product and HCT/P Deviation Report, Annual Summary for Fiscal Year 2010 (FDA/CBER) |
| Mar. 6, 2011 |
Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcripts: Oct. 28, 2010 & Oct. 29, 2010 (FDA) |
| Feb. 23, 2011 |
Potential Transmission of Viral Hepatitis Through Use of Stored Blood Vessels as Conduits in Organ Transplantation - Pennsylvania, 2009. MMWR, February 18, 2011 / 60(06);172-174. |
| Feb. 23, 2011 |
First Edition Paper: Vlaar APJ, et al. The incidence, risk factors and outcome of transfusion-related acute lung injury in a cohort of cardiac surgery patients: a prospective nested case control study. Blood, prepublished online February 16, 2011; DOI 10.1182/blood-2010-10-313973. |
| Feb. 23, 2011 |
First Edition Paper: Neunert C, et al.Clinical guideline update on "Immune thrombocytopenia: an evidence based practice guideline developed by the American Society of Hematology". Blood, prepublished online February 16, 2011; DOI 10.1182/blood-2010-08-302984. |
| Jan. 20, 2011 |
Ahead of Print Article: Haut ER, et al. Prehospital Intravenous Fluid Administration is Associated With Higher Mortality in Trauma Patients: A National Trauma Data Bank Analysis.Ann Surg. 2010 Dec 20. [Epub ahead of print]. Also see: Giving IV Fluids on Scene Might Raise Death Risk for Trauma Victims (MSN) |
| Jan. 20, 2011 |
Original Article: Kucirka LM, et al. Provider Response to a Rare but Highly Publicized Transmission of HIV Through Solid Organ Transplantation. Arch Surg. 2011;146(1):41-45. |
| Jan. 19, 2011 |
Recall of LEVEL 1 Normothermic I.V. Fluid Administration Sets (FDA/CBER) |
| Jan. 11, 2011 |
Compliance Program Guidance Manual Chapter 42 - Blood and Blood Products: Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001 (FDA/CBER) |
| Jan. 11, 2011 |
FDA BPAC Meeting Transcripts: Dec. 14, 2010 and Dec. 15, 2010 |
| Jan. 9, 2011 |
FDA News Release: FDA launches website to help regulated industries save time, resources |
| Jan. 9, 2011 |
December 14-15, 2010: Blood Products Advisory Committee Meeting Reference Document for Topics I and II (FDA) |
