| Date Posted |
Subject |
| Dec. 29, 2009 |
Press Release: Fenwal Receives FDA Approval for New Solution Used to Store Donated Blood Platelets. InterSol® platelet additive solution approved for use exclusively with the Fenwal® Amicus® system (Fenwal, Inc.) |
| Dec. 26, 2009 |
Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components, October 2009, updated Dec 2009 for technical correction [PDF file-for immediate implementation] (FDA/CBER) |
| Dec. 26, 2009 |
First Edition Paper: Kremer Hovinga JA, Survival and relapse in patients with thrombotic thrombocytopenic purpura. Blood. Prepublished online December 23, 2009; DOI 10.1182/blood-2009-09-243790. |
| Dec. 13, 2009 |
First Edition Paper: Rotta M, et al. Donor statin treatment protects against severe acute graft-versus-host disease after related allogeneic hematopoietic cell transplantation. Blood. prepublished online December 4, 2009; DOI 10.1182/blood-2009-08-240358. |
| Dec. 4, 2009 |
First Edition Paper: Canault M, et al. p38 mitogen-activated protein kinase activation during platelet storage: consequences for platelet recovery and hemostatic function in vivo. Blood. prepublished online Nov 30, 2009; DOI 10.1182/blood-2009-03-211706. |
| Nov. 20, 2009 |
Tiny chip could diagnose disease (BBC News) Also see Article: Gervais L, Delamarche E. Toward one-step point-of-care immunodiagnostics using capillary-driven microfluidics and PDMS substrates.Lab Chip. 2009 Dec 7;9(23):3330-7. |
| Nov. 20, 2009 |
Your Own Stem Cells Can Treat Heart Disease (Northwestern University) |
| Nov. 11, 2009 |
November 16-17, 2009: Blood Products Advisory Committee Meeting Materials [includes agenda and related documents] (FDA/CBER) |
| Nov. 7, 2009 |
AABB Association Bulletin #09-08: ISBT 128 Conditional Accreditation Status (AABB Membership required to access) |
| Oct. 30, 209 |
Urgent Medical Device Removal: COBAS AmpliPrep/COBAS Amplicor HIV-1 Monitor Test (FDA/CBER) |
| Oct. 29, 2009 |
DRAFT Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications [PDF file] (FDA/CBER) |
| Oct. 29, 2009 |
Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications [PDF file] (FDA/CBER) |
| Oct. 18, 2009 |
Safety Alert: Dexferrum (iron dextran injection) - Labeling Change (FDA: Medwatch) |
| Oct. 18, 2009 |
First Edition Paper: Abbott LS, et al. The impact of prophylactic fresh frozen plasma and cryoprecipitate on the incidence of CNS thrombosis and hemorrhage in children with acute lymphoblastic leukemia receiving asparaginase. Blood, prepublished online October 12, 2009; DOI 10.1182/blood-2009-07-231084. |
| Oct. 8, 2009 |
Article: Michel M, et al. The spectrum of Evans syndrome in adults: new insight into the disease based on the analysis of 68 cases. Blood, 8 October 2009, Vol. 114(15):3167-72. |
| Oct. 3, 2009 |
Blood banks retooling to manage growth of biologics
& Blood bank information systems product guide (CAP Today, PDF file) |
| Oct. 3, 2009 |
Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (FDA/CDER & CBER) |
| Sept. 21, 2009 |
Article: Triulzi DJ, et al. The effect of previous pregnancy and transfusion on HLA alloimmunization in blood donors: implications for a transfusion-related acute lung injury risk reduction strategy. Transfusion. 2009 Sep;49(9):1825-35. |
| Sept. 14, 2009 |
NJ: 29 hepatitis cases tied to 1 doctor's office (Associated Pres) |
| Sept. 14, 2009 |
FDA News: FDA Updates "Warning Letters" Web page |
| Sept. 9, 2009 |
Breakthrough Discoveries of Alzheimer's Genes (Time) Also see: Letter Abstract Published Online: Lambert J-C, et al. Genome-wide association study identifies variants at CLU and CR1 associated with Alzheimer's disease. Nature Genetics.
6 September 2009 | doi:10.1038/ng.439. |
| Sept. 1, 2009 |
2010 Traveler's Health Yellow Book: includes ordering info for hard copy, access to the online edition, and archived list of permanent updates to the 2010 edition (CDC) |
| Sept. 1, 2009 |
First Edition Paper: Verneris MR, et al. Relapse risk after umbilical cord blood transplantation: enhanced graft versus leukemia effect in recipients of two units. Blood. Prepublished online August 25, 2009; DOI 10.1182/blood-2009-05-220525. |
| Aug. 31, 2009 |
Guidance for Industry: Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection (FDA/CBER) |
| Aug. 25, 2009 |
Dispatch: Klevens RM, et al. Population-based surveillance for hepatitis C virus, United States, 2006–2007. Emerg Infect Dis. 2009 Sep; [Epub ahead of print] |
| Aug. 25, 2009 |
Draft Guidance for Industry: User Facilities and FDA Staff: eMDR - Electronic Medical Device Reporting (FDA/CDRH) |
| Aug. 25, 2009 |
Article: Hecht-Dolnik M, et al. Hetastarch increases the risk of bleeding complications in patients after off-pump coronary bypass surgery: A randomized clinical trial. J Thorac Cardiovasc Surg 2009;138:703-711. |
| Aug. 20, 2009 |
Ending the Federal Ban on Gay Blood Donations: Assembly Judiciary Committee passed AJR 13, the U.S. Blood Donor Nondiscrimination Resolution, calling upon the FDA to to adopt a policy that would lift the current deferral for MSM. (California Progress Report). See AJR 13 (Ammiano) Legislative Counsel's Digest. |
| Aug. 18, 2009 |
Transcripts and other items from the July 20-21, 2009 Meeting of the Blood Products Advisory Committee (FDA/CBER) |
| Aug. 14, 2009 |
Immucor Follow Up Letter to Customers, Aug 10, 2009 |
| Aug. 14, 2009 |
APHL HIV Testing Algorithms - Status Report 2009 (Association of Public Health Laboratories) |
| Aug. 3, 2009 |
New HIV Strain Discovered in Woman From Cameroon (NY TImes) Also see: Brief Communication abstract: Plantier J-C, et al. A new human immunodeficiency virus derived from gorillas. Nature Medicine
Published online: 2 Aug 2009 |
| July 31, 2009 |
Research Article: Rogers MAM, et al. Hospital variation in transfusion and infection after cardiac surgery: a cohort study. BMC Medicine 2009, 7:37, 31 July 2009. Also see: Blood transfusions 'double risk of infection for heart bypass patients' (Telegraph, UK) |
| July 31, 2009 |
First Edition Paper: Michel M, et al. The spectrum of Evans' syndrome in adults: new insight into the disease based on the analysis of 68 cases. Blood, prepublished online July 28, 2009; DOI 10.1182/blood-2009-04-215368. |
| July 31, 2009 |
Untitled Letter: C1 Esterase Inhibitor (Human)(Cinryze) Lev Pharmaceuticals, Inc. (FDA/CBER) |
| July 29, 2009 |
Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products (FDA/CBER) |
| July 29, 2009 |
Barcode replacement shown off: A replacement for the black and white stripes of the traditional barcode has been outlined by US researchers (BBC News) |
| July 24, 2009 |
Association Bulletin #09-05: ISBT 128 Implementation (AABB Membership required to access) |
| July 24, 2009 |
Direct Recall Classification Program (Blood and Plasma) (FDA/CBER) |
| July 24, 2009 |
Personal Best: Seeking Help for an Injury, at Any Price (NY Times) |
| July 24, 2009 |
Untitled Letter: Immune Globulin Intravenous (Human), 10 Percent Caprylate/Chromatography Purified (Gamunex, Talecris Biotherapeutics, Inc. (FDA/CBER) |
| July 24, 2009 |
Untitled Letter: InVitro Diagnostics: unapproved '10 minute' HIV test kit (FDA/CBER) |
| July 21, 2009 |
Association Bulletin #09-04: Developments in Bacterial Testing and BBTS Standard 5.1.5.1 (AABB Membership required to access) |
| July 21, 2009 |
New Alzheimer's Treatment Could Be on the Horizon. Potential of immune system treatment is 'exciting,' expert says (HealthDay News) |
| June 30, 2009 |
Immucor Working Diligently to Improve Quality System and Processes: See: Immucor's Letter and Q&A to Customers, Immucor Press Release, and FDA Notice |
| June 18, 2009 |
First Edition Paper: Desmarets M, et al. Minor histocompatibility antigens on transfused leukoreduced units of red blood cells induce bone marrow transplant rejection in a mouse model. Blood. prepublished online June 12, 2009; DOI 10.1182/blood-2009-04-214387. |
| June 11, 2009 |
Original Article: Gaines AR, et al. Investigation of whether the acute hemolysis associated with Rho(D) immune globulin intravenous (human) administration for treatment of immune thrombocytopenic purpura is consistent with the acute hemolytic transfusion reaction model (Transfusion reprint posted on FDA website) |
| June 11, 2009 |
Marrow donors elusive for multiracial patients: Just a tiny fraction of donors on the national registry are of mixed race (MSNBC) |
| May 30, 2009 |
First Edition Paper: Anstee, David J. Red cell genotyping and the future of pre-transfusion testing. Blood. prepublished online May 1, 2009 |
| Apr. 27, 2009 |
First Edition Paper: Cines DB, et al. The ITP syndrome: pathogenic and clinical diversity. Blood. Prepublished online April 24, 2009. DOI 10.1182/blood-2009-01-129155. |
| Apr. 24, 2009 |
CDRH Event Problem Codes: Provides a preview to the updates that will be going live July 1, 2009 (FDA/CDRH) |
| Apr. 16, 2009 |
Article: Pulsipher MA, et al. Adverse events among 2408 unrelated donors of peripheral blood stem cells: results of a prospective trial from the National Marrow Donor Program. Blood, 9 April 2009, 113(15):3604-11. |
| Apr. 7, 2009 |
Joint Commission deletes stringent recipient notification standard |
| Mar. 31, 2009 |
News Story: Army medicine: Untested in battle. New procedures were rushed into theaters of war without rigorous review (Baltimore Sun) |
| Mar. 28, 2009 |
Notice: Low cost loans available for California Non-Profit Health Care Facilities (CA Treasurer's Office) |
| Mar. 28, 2009 |
Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (FDA/CBER) |
| Mar. 19, 2009 |
Urgent Instruction
Correction: Biotest
Tango Automated Blood Bank Analyzer (FDA/CBER) |
| Mar. 16, 2009 |
Urgent Notification: Package
Insert Update for MLB2 Modified LISS Solution (FDA/CBER) |
| Mar. 16, 2009 |
Class 1 Recall: Baxter
Colleague Single and Triple Channel Volumetric Infusion Pumps (FDA/CDRH) |
| Mar. 16, 2009 |
Study
links blood types to pancreatic cancer risk (Reuters) |
| Mar. 16, 2009 |
Full Text Article: Ramsey,
G; CAP Transfusion Medicine Resource Committee. Inaccurate
Doses of Rh Immune Globulin After Rh-Incompatible
Fetomaternal Hemorrhage: Survey of Laboratory Practice.
Arch Pathol Lab Med. 2009 Mar;133(3):465-9. Also see associated Editiorial:
Land KJ, et al. Worried
That Your Laboratory Doesn't Measure Up? |
| Mar. 16, 2009 |
Full Text Article:
Valentin A, et al.Errors
in administration of parenteral drugs in intensive
care units: multinational prospective study. BMJ. 2009 Mar 12;338:b814. |
| Mar. 16, 2009 |
Ex-Biopure
exec pleads guilty to faking cancer (Washington Post) |
| Mar. 6, 2009 |
Report: Hepatitis
C Virus Transmission at an Outpatient Hemodialysis Unit — New York, 2001-2008. MMWR.
March 6, 2009 / 58(08);189-194. |
| Mar. 6, 2009 |
Press Release: LabCorp Announces
Appointment of Dr. Mark Elliott Brecher As Chief Medical Officer |
| Feb. 26, 2009 |
News Story: Man
sues over unwanted transfusion (Connecticut Post) |
| Feb. 21, 2009 |
Original Article: The International
Warfarin Pharmacogenetics Consortium. Estimation
of the Warfarin Dose with Clinical and Pharmacogenetic
Data. N Engl J Med. 2009 Feb 19;360(8):753-764. |
| Feb. 20, 2009 |
Presentation from
5th Annual FDA and the Changing Paradigm for HCT/P
Regulation - 1/2009: Writing
An Effective 483 Response (FDA/CBER) |
| Feb. 20, 2009 |
News
Story: A
Promising Treatment for Athletes, in Blood (NY Times) |
| Feb. 10, 2009 |
First Edition Paper: Stasi
R, et al. Effects
of eradication of Helicobacter pylori infection in patients with immune
thrombocytopenic purpura: a systematic review. Blood, 5 Feb 2009, Vol. 113, No.
6, pp. 1231-40. |
| Feb. 10, 2009 |
CDER News: Early
Communication about an Ongoing Safety Review Xigris (Drotrecogin
alfa [activated]) (FDA/CDER) |
| Feb. 5, 2009 |
First Edition Paper: Vamvakas EC, Blajchman MA. Transfusion-related mortality: The ongoing risks of allogeneic blood transfusion and the available strategies for their prevention. Blood. Prepublished online February 2, 2009; DOI 10.1182/blood-2008-10-167643. |
| Jan. 31, 2009 |
Article: Dodd B, Vetter RJ. Replacement of 137Cs Irradiators with X-ray Irradiators. Health Physics 2009 (Feb);96(suppl 2):S27-S30. |
| Jan. 18, 2009 |
Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for
Manufacturers of Human Cells, Tissues, and Cellular
and Tissue-Based Products (HCT/Ps) (FDA/CBER) |
| Jan. 18, 2009 |
Letter: Martin TM, Rich JD. Fatal HIV Encephalitis in HIV-Seronegative Patients. Emerg Infect Dis. 2009 Jan. 53(1):129. |
| Jan. 13, 2009 |
First Edition Paper: Lund N et al. The human Pk histo-blood group antigen provides protection against HIV-1 infection. Blood. Prepublished online January 12, 2009; DOI 10.1182/blood-2008-03-143396. |
| Jan. 13, 2009 |
Investigation of Patients Treated by an HIV-Infected Cardiothoracic Surgeon - Israel, 2007. MMWR. Jan. 9, 2009 / 57(53);1413-15. |
| Jan. 11, 2009 |
Feature Story: Soon, all eyes on better blood use (CAP Today) |
| Jan. 8, 2009 |
First Edition Paper: A randomized controlled trial comparing standard and low-dose strategies for transfusion of platelets (SToP) to patients with thrombocytopenia. Blood. Prepublished online December 24, 2008; DOI 10.1182/blood-2008-09-178236. |
| Jan. 1, 2009 |
FDA News: FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue |
