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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 11/1/13-11/1/13

Meeting Details:

On November 1, 2013, the Committee will meet in open session to discuss MP Biomedicals' biologic license application for the MP Diagnostics HTLV Blot 2.4, a Western Blot intended for use as a confirmatory test for blood donors. In the afternoon, the committee will hear update presentations on the following topics: (1) The April 2013 FDA public workshop on multiplex detection of transfusion transmissible agents and blood cell antigens in blood donations and (2) FDA safety communications on new boxed warnings for immune globulin products and hydroxyethyl starch solutions. Following the update presentations, the committee will meet in open session to hear presentations on the research programs of the Laboratory of Biochemistry and Vascular Biology, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 2/12/13-2/12/13

Meeting Details:

On February 12, 2013, the Committee will meet in open session to discuss Cangene’s biologics license application for Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) seeking licensure under FDA’s authority to approve a product based on evidence of safety in humans and effectiveness from studies in animals when human efficacy studies are not ethical or feasible.

 

       
Location: Fishers Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 8/2/11-8/3/11

Meeting Details:

On August 2, 2011, the committee will discuss a study on the incidence of Trypanosoma cruzi infection in blood donors and its implications for selective testing of blood donors. On August 3, 2011, the committee will discuss measures to preserve the blood supply during a severe emergency. In the afternoon, the committee will hear the following updates: Summary of the June 7-8, 2011, Health and Human Services Advisory Committee on Blood Safety and Availability meeting; summary of the May 17-18, 2011, public workshop on risk mitigation strategies to address procoagulant activity in immune globulin products; and summary of the August 1-2, 2011, Transmissible Spongiform Encephalopathies Advisory Committee meeting.

 

       
Location: Hilton - GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 4/28/11-4/29/11

Meeting Details:

On April 28, 2011, in the morning, the committee will discuss testing donations of Source Plasma for hepatitis B virus infection by nucleic acid testing. In the afternoon, the committee will discuss current considerations on use of plasma obtained from Whole Blood donors for further manufacturing. On April 29, 2011, in the morning, the committee will discuss blood donor written statement of understanding. In the afternoon, the Committee will hear an update from the Department of Health and Human Services' Office of the Assistant Secretary for Health and an update on public workshops FDA is considering sponsoring on thrombotic adverse events associated with Immune Globulin Intravenous, toxicities of Hydroxyethyl Starch Solutions, and measurement of hemoglobin in blood donors.

 

       
Location: Hilton Washington DC/North Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 12/14/10-12/15/10

Meeting Details:

On December 14, 2010, in the morning, the committee will discuss the risk of dengue virus infection in blood donors. In the afternoon, the committee will discuss murine leukemia virus-related human retroviruses and blood safety. On December 15, 2010, in the morning, the committee will hear updates on the following topics: (1) November 4 and 5, 2010, meeting of the Health and Human Services Advisory Committee on Blood Safety and Availability and (2) December 9 and 10, 2010, FDA workshop entitled “Product Development Program for Interventions in Patients With Severe Bleeding Due to Trauma and Other Causes,” and (3) Research programs in the Laboratories of Hemostasis and Plasma Derivatives, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 7/26/10-7/27/10

Meeting Details:

On July 26, in the morning session, the Committee will hear updates on the following topics: June 10-11, 2010 meeting of the HHS Advisory Committee on Blood Safety and Availability; December 14-15, 2009 FDA workshop on emerging arboviruses; May 11-12, 2010 FDA workshop on emerging infectious diseases; and the Q fever epidemic in the Netherlands. The Committee will also hear informational presentations on Xenotropic Murine Leukemia Virus-Related Virus (XMRV). In the afternoon session, the Committee will discuss issues related to the risk of Babesia infection by blood transfusions and the status of laboratory tests. On July 27, the Committee will discuss blood donor hemoglobin/hematocrit qualifications standards, iron status and interdonation interval.

 

       
Location: Hilton Washington Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 11/16/09-11/17/09

Meeting Details:

On November 16, 2009, in the morning the Committee will hear updates on the following topics: the HHS Advisory Committee on Blood Safety and Availability, Dengue virus outbreak, and 2009 A/H1N1 Pandemic and the impact on blood safety and availability. The Committee will then discuss blood donor deferral for malaria risk associated with travel to Mexico. In the afternoon the Committee will discuss the design of a new phase III study of pathogen inactivation of human platelets using the Cerus, INTERCEPT Blood System. On November 17, 2009, in the morning the Committee will discuss blood pressure and pulse as blood donor eligibility criteria, and in the afternoon the committee will discuss the public health need and performance characteristics of over-thecounter home-use HIV test kits.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 7/20/09-7/21/09

Meeting Details:

On July 20, 2009, in the morning, the Committee will review proposed strategies to demonstrate the effectiveness of new coral snake antivenoms. In the afternoon the Committee will discuss alternative clinical and surrogate endpoints for evaluating efficacy of Alpha-1 Proteinase Inhibitor (Human) augmentation therapy in Alpha-1 antitrypsin deficiency. Alpha-1 antitrypsin deficiency is a genetic condition associated with decreased circulating levels of alpha-1 antitrypsin that significantly increases the risk of serious lung disease (i.e. emphysema) in adults. On July 21, 2009 the Committee will hear updates on the following topics: April 30-May 1, 2009 meeting of the DHHS Advisory Committee on Blood Safety and Availability; June 12, 2009 meeting of the FDA Transmissible Spongiform Encephalopathies Advisory Committee; and an overview of the epidemiology and virology of the 2009 A/H1N1 influenza virus and its impact on the U.S blood system. The Committee will also hear informational presentations on recent public and private hemovigilance efforts, including the pilot hemovigilance module in the National Healthcare Safety Network.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 4/1/09-4/2/09

Meeting Details:

On April 1, 2009, the committee will hear updates on the following topics: National Biovigilance Data Collection and Analysis Program; a summary of the December 16 and 17, 2008, meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; and a summary of the September 12, 2008, FDA Workshop on Approaches to Minimize the Risk of Transfusion-Transmitted Babesiosis in the United States. The committee will then discuss blood donor screening and testing donors of human cells, tissues and cellular and tissue-based products (HCT/Ps) for hepatitis B virus infection by nucleic acid testing. In the afternoon, the committee will discuss potential testing strategies for Trypanosoma cruzi infection in blood donors. On April 2, 2009, the committee will discuss FDA's current considerations on plasma obtained from a Whole Blood donor for further manufacturing use and in the afternoon will review the research programs in the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, CBER Site Visit held on October 22, 2008.

 

       
Location: Hilton Washington Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 1/9/09-1/9/09

Meeting Details:

On the morning of January 9, 2009, the Committee will discuss CSL Behring's Biologics License Application for plasma-derived fibrinogen concentrate for treatment of bleeding in congenital fibrinogen deficiency. In the afternoon, the Committee will hear an update on the ``Food and Drug Administration Draft Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable Recombinant Deoxynucleic Acid Constructs.'' Following this update, the Committee will discuss GTC Biotherapeutics' Biologics License Application for recombinant Antithrombin III derived from genetically engineered goats for treatment of patients with hereditary Antithrombin III deficiency to prevent thrombosis during high risk situations like surgery and obstetrical procedures.

 

       
Location: Hilton Hotel Rockville, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 9/10/08-9/11/08

Meeting Details:

Agenda: On the morning of September 10, 2008, the Committee will hear an update on the May 29 to 30, 2008, meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability. Following this update, the Committee will discuss strategies to enhance bacterial safety of 7 day platelets for transfusion. In the afternoon, the Committee will discuss iron status in blood donors. On September 11, 2008, the Committee will hear updates on the following topics: (1) April 29 to 30, 2008, workshop on hemoglobin based oxygen carriers; (2) July 10 to 11, 2008, blood establishment computer software conference; (3) the development of an automated Biologics License Application submission system; and (4) Draft Guidance for Industry: Re-qualification Method for Re-entry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc).

 

       
Location: Hilton Hotel Rockville, MD 20852 Related News Links: Not Available
Time: 8:00AM-5:45PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 5/1/08-5/2/08

Meeting Details:

On the morning of May 1, 2008, the committee will hear updates on the following: (1) Summaries of August 22–23, 2007, and January 9–10, 2008, meetings of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; (2) 2007 West Nile Virus Epidemiology and the use of nucleic acid tests to reduce the risk of transmission of West Nile Virus in Whole Blood and blood components for transfusion and Human Cells, Tissues, and Cellular and Tissue-based products (HCT/Ps); (3) implementation of blood donor screening for infection with Trypanosoma cruzi and the use of serological tests to reduce the risk of transmission of T. cruzi infection in Whole Blood and blood components for transfusion and HCT/Ps; (4) FDA’s proposal to lower the minimum recommended lot release titer for measles antibodies in Immune Globulin Intravenous (Human) and Immune Globulin Subcutaneous (Human); (5) Gambro/Fenwal Post Approval Surveillance Study of Platelet Outcomes, Release Tested (PASSPORT) Post Marketing Study—7 Day Platelets; (6) Experience with 7 Day Platelets Versus 5 Day Platelets; and (7) FDA Perspective on the PASSPORT Study. These updates will be followed by informational presentations on FDA’s Center for Biologics Evaluation and Research Safety Teams related to blood and tissue. In the afternoon, the committee will discuss the Biomedical Excellence for Safer Transfusion Committee Report on red blood cell recovery standards. On the morning of May 2, 2008, the committee will discuss Lev Pharmaceutical’s plasma-derived C1 esterase inhibitor (CINRYZE). Then, in the afternoon the committee will review the research programs in the Laboratory of Hepatitis and Related 3 Emerging Agents, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, CBER Site Visit of November 8, 2007.

 

       
Location: Hilton Hotel Washington DC/Rockville Executive Meeting Center 1750 Rockville Pike Rockville, MD 20852 Related News Links: Not Available
Time: 8:30AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 8/16/07-8/16/07

Meeting Details:

On August 16, 2007, the Committee will hear updates on the following topics: (1) Summary of the May 10 through 11, 2007, and the August 6 through 7, 2007, meetings of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; (2) summary of the April 25 through 26, 2007, FDA Workshop on Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing; and (3) summary of the August 15, 2007, FDA Workshop on Licensure of Apheresis Blood Products. The Committee will then hear informational presentations relating to World Health Organization (WHO) biological standards on the following topics: (1) Summary of the January 29 through 30, 2007, WHO meeting with WHO collaborating centers for biological standards and standardization to support the development of WHO biological reference preparations for high risk blood safety-related in vitro diagnostics; (2) potency and safety standards for plasma derivatives; and (3) joint FDAIWHO minimum potency standards for certain blood grouping reagents. The Committee will hear the response of the Office of Blood Research and Review to their office level site visit of July 22, 2005. In the afternoon the Committee will discuss measles antibody levels in U.S. Immune Globulin products.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 4/26/07-4/27/07

Meeting Details:

On April 26, 2007, the committee will hear an update on a summary of August 30 and 31, 2006, meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability. The committee will then discuss issues related to implementation of blood donor screening for infection with Trypanosoma cruzi and issues related to transmissibility of Trypanosoma cruzi in donors of human cells, tissue, and cellular and tissue-based products. On April 27, 2007, the committee will hear updates on summary of December 15, 2006, meeting of the Transmissible Spongiform Encephelopathies Advisory Committee, FDA's risk communication on plasma-derived Factor VIII and Factor XI, and summary of September 25 and 26, 2006, FDA Workshop on Molecular Methods in Immunohematology. The committee will then discuss transfusion related acute lung injury, and discuss issues related to implementation of blood donor screening for infection with West Nile Virus.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 12/14/06-12/14/06

Meeting Details:

On December 14, 2006, the committee will hear an update summary of the October 11, 2006, Public Hearing on Emergency Research. The committee will then discuss pre-clinical and clinical studies of the hemoglobin-based oxygen carrier, bovine polymerized hemoglobin (HBOC-201). In addition, the committee will discuss an emergency research study of HBOC-201, proposed by the Naval Medical Research Center. FDA intends to make background material available to the public no later than one business day before the meeting.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 7/13/06-7/14/06

Meeting Details:

On July 13, 2006, in the morning the Committee will hear updates on the following topics: (1) Summary of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability meeting held May 9 & 10, 2006; (2) Summary of the workshop on Testing for Malarial Infections in Blood Donors to be held July 12 2006; (3) Committee report on the Office of Blood Research and Review Site Visit, Review of Intramural Research; (4) West Nile Virus Update;. (5) FDA acceptance criteria for in vivo red blood cell survival studies. The Committee will discuss the FDA review of Nabi Biopharmceuticals’ Hepatitis B Immunoglobulin Intravenous (IGIV) for prevention of recurrent Hepatitis B Virus (HBV) Disease after othotopic liver transplantation. In the afternoon, the Committee will hear an overview of the research program of the Laboratory of Bacterial, Parasitic and Unconventional Agents, Division of Emerging and Transfusion Transmitted Diseases, OBRR, CBER. On July 14, 2006, from 8 a.m. to 3:30 p.m. the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 3/9/06-3/10/06

Meeting Details:

On March 9, 2006, in the morning the committee will hear updates on the following topics: (1) Summary of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability January 2006 meeting; (2) current considerations for blood donor screening for West Nile Virus; (3) classification of transfusion recipient identification (ID) systems; and (4) summary of the workshop on behavior-based donor deferrals in the Nucleic Acid Test (NA T) era. The committee will then discuss rapid tests for detection of bacterial contamination of platelets. In the afternoon, the committee will discuss public comments on the "Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods (DRAFT)." On March 10, 2006, in the morning the committee will discuss proposed studies to support the approval of over the-counter (OTC) home-use human immunodeficiency virus (HIV) test kits. In the afternoon, the committee will hear an overview of the research programs of the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), as presented to a subcommittee of the Blood Products Advisory Committee during their site visit on July 22, 2005, and discuss a subcommittee report in closed session. Additionally, the committee will hear an overview of the research programs in the Laboratory of Biochemistry and Vascular Biology and the Laboratory of Cellular Hematology, Division of Hematology, Office of Blood Research and Review, CBER and in closed session discuss the report from the laboratory site visit of October 6, 2005.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 11/3/05-11/4/05

Meeting Details:

On November 3, 2005, in the morning, the committee will hear updates on the following topics: (1) West Nile Virus; (2) draft guidance on nucleic acid testing (NAT) for human immunodeficiency virus (HIV)-1 and hepatitis C virus (HCV): Testing, product disposition, and donor deferral and re-entry; (3) summary of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability held on September 19 and 20, 2005; and (4) re-entry of donors deferred based on hepatitis B core antigen (anti-HBc) test results. The committee will discuss approaches to over-the-counter (OTC) home-use HIV test kits the rest of the day. On November 4, 2005, in the morning, the committee will hear information on serious adverse events resulting from interference with measurement of blood glucose following infusion of maltose-containing immune globulin intravenous (human) and will discuss Alpha-1-Proteinase Inhibitor products. In the afternoon, the committee will hear an overview of the research programs of the Office of Blood Research and Review, Center for Biologics Evaluation and Research, as presented to a subcommittee of the Blood Products Advisory Committee during their site visit on July 22, 2005, and discuss a subcommittee report.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 9/29/05-9/29/05

Meeting Details:

On September 29, 2005, the committee will discuss new drug application (NDA) 21-882 proposed trade name EXJADE (deferasirox) Tablets for Oral Suspension, Novartis Pharmaceutical Corp., proposed for the indication of the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis). Following this discussion, the committee will hear an overview of the research programs in the Laboratory of Hemostasis and the Laboratory of Plasma Derivatives, Division of Hematology, Office of Blood Research and Review, CBER, and in closed session will discuss the report from the laboratory site visit of February 25, 2005.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsResearch Review Subcommittee of the Blood Products Advisory Committee

Meeting Date: 7/22/05-7/22/05

Meeting Details:

On July 22, 2005, the subcommittee will listen to presentations to further a dynamic, responsive, and cutting edge research program in the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), that facilitates development of safe and effective biological products. The subcommittee’s recommendations will be publicly discussed at a future meeting of the Blood Products Advisory Committee. Information regarding CBER’s scientific program is outlined in its Strategic Plan of 2004 and is available to the public on the internet at: http://www.fda.gov/cber/inside/mission.htm. Information regarding FDA’s Critical Path to New Medical Products is available to the public on the internet at: http://www.fda.gov/oc/initiatives/criticalpath/.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:00AM-2:15PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 7/21/05-7/21/05

Meeting Details:

On July 21, 2005, in the morning, the Committee will hear updates on the following topics: (1) Summary of the May 2005 meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; (2) disseminated intravascular coagulation associated with acute hemoglobinemia following anti-D Immune Globulin Intravenous administration for idiopathic thrombocytopenic purpura; (4) update on safety of albumin; (5) summary of June 2005 workshop on Biological Therapeutics for Rare Plasma Protein Disorders; (6) summary of July 2005 workshop on Leukoreduction and updates on West Nile Virus guidance. The Committee will discuss management of donors and units that test positive for Hepatitis B Virus DNA by nucleic acid tests. In the afternoon the Committee will discuss the scientific basis for review of Varicella Zoster Immune Globulin and Dextran 1 pre-treatment for safe use of Dextran 40/70.

 

       
Location: HOL-GB Related News Links: Not Available
Time: 8:00AM-6:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 3/17/05-3/18/05

Meeting Details:

On March 17, 2005, the Committee will hear updates on the following topics: summary of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability meeting; summary of the Transmissible Spongiform Encephalopathies Advisory Committee meeting; update on West Nile Virus guidance; and summaries of the Critical Path Initiative workshop. In the morning, the Committee will also discuss and provide recommendations on the safety of albumin. In the afternoon, the Committee will hear additional updates on the following topics: international agreements and a presentation on sharing information with the public. Additionally, the Committee will hear presentations, discuss and provide recommendations on rapid freezing of plasma for transfusion. On the morning of March 18, 2005, the Committee will hear presentations, discuss and provide recommendations on the study design for the abbreviated uniform donor history questionnaire. The Committee also will hear presentations related to the review of the site visit report for the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 10/21/04-10/22/04

Meeting Details:

On October 21, 2004, the Committee will hear updates on: Summary of the Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC) meeting discussion of new variant Creutzfeldt-Jacob disease (vCJD) transmission by transfusion in the United Kingdom and supplemental testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV). In the morning, the Committee will also discuss and provide recommendations on the agency’s current thinking on re-entry of donors previously deferred for anti-HBc reactivity. In the afternoon, the Committee will discuss and provide recommendations on the potential risk of transmission of Simian Foamy Virus (SFV) by blood transfusions. On October 22, 2004, the Committee will hear updates on: a summary of the Plasma Workshop held on August 31-September 1, 2004, draft uniform donor health questionnaire acceptance guidance: review of public comments, and FDA current thinking on monitoring weight in source plasma donors. The Committee will also hear presentations, discuss and provide recommendations on the agency’s current thinking on donor deferral for potential or documented infection with West Nile Virus (WNV).

 

       
Location: Holiday Inn Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 7/22/04-7/23/04

Meeting Details:

On July 22, 2004, the committee will hear updates on: FDA current thinking on transfusion related acute lung inflammation (TRALI), and donor blood pressure determination. The committee will also discuss and provide recommendations on the dating of irradiated blood. In the afternoon, the committee will discuss and provide recommendations on the new standards for platelet evaluation and experience with monitoring of bacterial contamination of platelets. On July 23, 2004, the committee will hear an update on West Nile Virus. The committee will also hear presentations, discuss and provide recommendations on hepatitis B virus nucleic acid testing (HBV NAT) for mini-pools. In the afternoon, there will be an informational presentation on current trends in plasma product manufacturing.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 3/18/04-3/19/04

Meeting Details:

Current thinking on draft documents, Nucleic acid testing, HIDV, hepatitis C testing product disposition and donor deferral and re-entry. Current thinking on final guidances for use of nucleic acid testing on pooled and individual samples from donors on whole blood and blood components on adequatedly and unappropriately reduce the risk of transmission of HIV 1 and HCV and current thinking on variances to address the specificity issues of Ortho HbsAg 3.0 assays. The committe will also hear presentations discuss and provide recommendations on clinical trials for licenses hepatitis B and immune globulin and treatment to prevent hepatitis B virus and reinfection of liver disease following liver transplantation in hbv positive recipients in the afternoon the committee. I will hear presentations discuss and provide recommendations on supplemental testing hiv and hepatitis C virus. On March 19th 8-3pm, the committee will hear presentations and discuss and provide recommendations on platelet apheresis on quality control. A statistical quality control model and hear presentations revelent to the site visit report on the review on the research programs of the laboratory of hepatitis and emerging bacterial agents and the laboratory of bacterial and parasitic and unconventional agents.

 

       
Location: Holiday Inn Gaithersburg, Md. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 12/11/03-12/12/03

Meeting Details:

On December 11, 2003, the committee will hear presentations, discuss and provide recommendations on the following topics: the American Association for Blood Banks (AABB) Abbreviated Donor Questionnaire; and blood donor deferral for exposure to Leishmaniasis. In the afternoon, the committee will hear an update on the West Nile Virus (WNV) epidemic and donor testing in 2003, including updates on WNV testing under investigational new drug applications and plans for 2004. On December 12, 2003, the committee will hear updates on the following topics: the medical device user fee act; the use of secure E-mail; a summary of the factor VIII inhibitor workshop; platelet testing and evaluation guidance; and freezing and storage temperatures for source plasma (-25 °C and –30 °C). The committee will also hear presentations, discuss and provide recommendations on the review of plasma collection nomograms.

 

       
Location: Hilton DC North-Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 9/18/03-9/18/03

Meeting Details:

On September 18, 2003, the following committee updates are tentatively scheduled: 1) Announcement of appointment of the new Director, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, 2) summary of Public Health Service Advisory Committee on Blood Safety and Availability, 3) summary of National Heart, Lung and Blood Institute workshop on pathogen reduction and blood component safety, 4) approval of human immune deficiency virus, type 1 (HIV-1) group "O" sensitive assays, 5) revised guidance on Severe Acute Respiratory Syndrome, 6) updated donor travel survey; and 7) labeling and storage: blood and blood components (proposed regulation). In the morning, the committee will also hear informational presentations on 1) an overview of counterterrorism exercise, and 2) the current status of West Nile Virus safety. In the afternoon, the committee will hear presentations, discuss and provide recommendations on the topic of supplemental testing for HIV-1 and hepatitis C virus.

 

       
Location: Gaithersburg Hilton Hotel Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 6/19/03-6/20/03

Meeting Details:

In open session on June 19, 2003, the committee will hear updates on the following tentative topics: Medical Device User Fee and Modernization Act (MDUFMA), Secure E-mail and Electronic Submissions, White Particulate Matter in Blood Bags, and Safety Reporting Requirements for Human Drug and Biological Products. The committee will further hear informational presentations on Severe Acute Respiratory Syndrome (SARS) and West Nile Virus (WNV). In open session on June 20, 2003, the committee will hear presentations, discuss and provide recommendations on the topic of recovered plasma. In the afternoon, the committee will hear an informational presentation on Vaccinia Immune Globulin Intravenous (VIGIV): current thinking and indications for use.

 

       
Location: Hilton Gaithersburg Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 3/13/03-3/14/03

Meeting Details:

On March 13, 2003, the following committee updates are tentatively scheduled: FDA consolidation, Medical Device User Fee and Modernization Act (MDUFMA), Clinical Laboratory Improvement Amendments (CLIA) waiver for human immunodeficiency, type 1 (HIV-1) rapid tests, and Trans Net pilot program. The committee will hear presentations, discuss and provide recommendations on the topic of West Nile Virus (WNV) testing. On March 14, 2003, the following committee updates are tentatively scheduled: limitations on validation of anti-coagulant and additive solutions to permit freezing and irradiation of red cells, and particulates in blood bags. The committee will hear presentations, discuss and provide recommendations on the topic of extensions of the dating period for pooled platelets.

 

       
Location: Gaithersburg Hilton Related News Links: Not Available
Time: 8:00AM-6:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 12/12/02-12/12/02

Meeting Details:

The following committee updates are tentatively scheduled: current thinking on deferral of blood donors after smallpox vaccination, device user fees(MTEA), and human immunodeficiency (HIV) rapid tests. In the morning, the committee will hear presentations, discuss and provide recommendations on the topic of bacterial contamination. In the afternoon, the committee will hear presentations on human parvovirus B19 nucleic acid testing (NAT) for whole blood and source plasma, and discuss and provide recommendations.

 

       
Location: HOL - G Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 9/12/02-9/12/02

Meeting Details:

On September 12, the following committee updates are tentatively scheduled: consideration of the Clinical Laboratory Improvement Act (CLIA) waivers for rapid human immunodeficiency virus tests, implementation of human immunodeficiency virus, type 1/hepatitis C virus nucleic acid testing algorithm, summary of Public Health Service Advisory Committee on Blood Safety and Availability meeting held on September 5, 2002, summary of the workshop on pathogen inactivation held on August 7-8, 2002, and blood establishment registration-electronic submissions. In the morning, the committee will hear discussion and provide recommendations on the topic of self-administration of the uniform donor history questionnaire: first time donors. In the afternoon, the committee will hear an informational presentation on testing for Chagas disease, and a presentation on window period for human immunodeficiency virus (HIV) cases and current estimates of residual risk.

 

       
Location: Hilton Hotel Silver Spring, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 6/13/02-6/14/02

Meeting Details:

On June 13, 2002, committee updates on end user notification and HIV rapid tests are tentatively scheduled. The committee will hear an informational presentation on the shortage of western blot tests for HIV, and discuss and provide recommendations on standards for recovered plasma. In the afternoon, the committee will hear presentations, discuss and make recommendations on the uniform donor history questionnaire. On June 14, 2002, the following committee updates are tentatively scheduled: summaries of FDA/PPTA workshop on comparability of plasma derivatives, and the AABB conference on oxygen therapeutics. The committee will hear informational presentations on premarket submissions: in-vitro diagnostic software and instruments; and electronic submission of biologics license applications (BLA). The committee will hear presentations, discuss and make recommendations on the warning label for hetastarch and bleeding.

 

       
Location: Gaithersburg Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 3/14/02-3/15/02

Meeting Details:

On March 14, 2002, the following committee updates are tentatively scheduled: nucleic acid testing for whole blood, including standards for human immune deficiency virus and hepatitis C virus RNA, nucleic acid testing for parvovirus B19, nucleic acid testing for hepatitis A virus and announcement of planned FDA workshops. The committee will hear an informational presentation on emergency preparedness for the blood supply. In the afternoon, the committee will hear presentations, discuss and make recommendations on percutaneous exposure of blood and plasma donors: tattoos and body piercing. On March 15, 2002, the committee will hear informational presentations and have discussion on the review of data supporting extension of the dating period for platelets, and in the afternoon, bacterial and fungal safety of tissue.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 12/13/01-12/13/01

Meeting Details:

On December 13, 2001, the following committee updates are tentatively scheduled: transmissible spongiform encephalopathies (TSE) guidance, CDC workshop on factor VIII, update on disaster response, and compliance quality control oversight. In the morning, the committee will hear presentations, discuss and make recommendations on potential concerns for simian foamy virus (SFV) transmission by blood and blood products. In the afternoon, the committee will hear presentations, discuss and make recommendations on the leukocyte reduction guidance. On December 14, 2001, the committee will hear presentations, discuss and make recommendations on human cells, tissues and cellular and tissue-based products: risk factors for semen donation.

 

       
Location: Silver Spring, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 9/20/01-9/21/01

Meeting Details:

On September 20, 2001, the following committee updates are tentatively scheduled: transmissible spongiform encephalopathies (TSE) guidance, hepatitis B surface antigen lot release guidance, human immunodeficiency virus (HIV) and hepatitis C virus (HCV) nucleic acid testing, clinical laboratory improvement act (CLIA) waiver for HIV rapid tests, and compliance quality control oversight. In the morning, the committee will hear presentations, discuss and make recommendations on potential concerns for simian foamy virus (SFV) transmission by blood and blood products. In the afternoon, the committee will hear presentations, discuss and make recommendations on the leukocyte reduction guidance. On September 21, 2001, the committee will hear presentations, discuss and make recommendations on human cells, tissues and cellular and tissue-based products: risk factors for semen donation.

 

       
Location: Gaithersburg Hilton, Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 6/14/01-6/15/01

Meeting Details:

On June 14, 2001, the following committee updates are tentatively scheduled: summary of the Public Health Service Advisory Committee on Blood Safety and Availability meeting, and current thinking: clinical trial design and performance standards for approval of rapid HIV tests. In the morning, the committee will hear presentations, discuss and make recommendations on re-entry for donors deferred because of human immunodeficiency virus (HIV) or hepatitis C virus (HCV) nucleic acid testing (NAT) or serological test results. In the afternoon, the committee will hear presentations, discuss and make recommendations on the Clinical Laboratory Improvement Act (CLIA) criteria for in vitro diagnostic tests: applicability of waivers to HIV rapid tests, and an informational presentation on the revision of the uniform donor history questionnaire. On June 15, 2001, the following updates are tentatively scheduled: summaries of the Department of Health and Human Services and the Office of Blood Research and Review, Center for Biologics Evaluation and Research, respectively, transmissible spongiform encephalopathy (TSE) and bovine spongiform encephalopathy (BSE) action plans. In the morning, the committee will hear an informational presentation, discuss and make recommendations on transfusion-related acute lung injury. In the afternoon, the committee will hear presentations on studies on leukoreduction filtration failures.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 3/15/01-3/16/01

Meeting Details:

On March 15, 2001, the committee will hear presentations, discuss and make recommendations on the Abbott Prism Test System: Informational presentation only, and the Comparative Sensitivity of Hepatitis B Virus Nucleic Acid Testing (HBV NAT) vs. Hepatitis B Surface Antigen (HBsAg) testing. In the afternoon the committee will hear presentations, discuss and make recommendations on the Implementation of Nucleic Acid Testing (NAT) for Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV): Donor and Product Management, and Blood Bags for Diversion of the Initial Collection. On March 16, 2001, the committee will hear updates on the following topics: summaries of the Transmissible Spongiform Encephalopathies Advisory Committee Meeting and the PHS Advisory Committee on Blood Safety and Availability, and the Office of Inspector General Report on Tissue and Organ Regulation. In the morning, the committee will hear presentations, discuss and make recommendations on Male to Male Sex (MSM) Deferral Recommendations for Blood and Tissue Donors, Including Semen for Artificial Insemination, and in the afternoon, Guidance on Malaria: Applicability to Plasma.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products - Exclusive Coverage

Meeting Date: 9/14/00-9/15/00

Meeting Details:

On September 14, 2000, the following committee updates are tentatively scheduled: summary of the Public Health Service (PHS) Advisory Committee on Blood Safety and Availability meeting, hepatitis C virus lookback, factor VIII and von Willebrand factor standards, shortage issues (blood components and recombinant factor VIII). In the morning, the committee will hear presentations, discuss and make recommendations on HIV p24 antigen testing of plasma for fractionation: potential criteria for discontinuation. In the afternoon, the committee will hear presentations, discuss and make recommendations on deferral, as blood or plasma donors, of males who have had sex with males. On September 15, 2000, the following updated are tentatively scheduled: summaries of recent meetings and workshops on 1) recruiting blood donors: successful practices; 2) cord blood; 3) tissue meeting on bone products; and 4) the joint meeting of the Transmissible Spongiform Encephalopathies and the Vaccines and Related Biological Products Advisory Committees. In the morning, the committee will hear presentations, discuss and make recommendations on the current utility of screening blood donors for syphilis. In the afternoon, the committee will sit as a medical device panel for the classification of human leukocyte antigens(HLA) devices, and will hear the report of the intramural site visit of the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review.

 

       
Location: Gaithersburg Hilton Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products

Meeting Date: 6/15/00-6/16/00

Meeting Details:

On June 15, 2000, the committee will hear updates on summaries of the PHS Advisory Committee on Blood Safety and Availability meeting held April 25-26, 2000; the FDA Transmissible Spongiform Encephalopathies Advisory Committee meeting held June 1-2, 2000; the FDA sponsored workshop on plasticizers held on October 18, 1999, and a briefing on blood supply monitoring. The committee will also hear presentations and provide recommendations on plasma pool screening by nucleic acid tests for Hepatitis A virus and, in the afternoon, hear presentations and provide recommendations on the development of rapid HIV tests. On June 16, 2000, the committee will hear updates on requirements for syphilis testing; the risk of Hepatitis C virus to sexual partners; relative sensitivity of Hepatitis B surface antigen and Hepatitis B virus nucleic acid tests; and hear and discuss presentations on proposed FDA guidance on universal leukoreduction: current thinking.

 

       
Location: Holiday Inn Silver Spring, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 3/16/00-3/17/00

Meeting Details:

On March 16, the following Committee updates are tentatively scheduled: summaries of recent workshops on bacterial contamination of platelets, criteria for safety and efficacy evaluation of oxygen therapeutics as red cell substitutes, implementation of universal leukoreduction, and the NIH workshop on parvovirus B19. In the morning, the committee will hear presentations, discuss and make recommendations on a submitted proposal to revise the interpretation of indeterminate HIV-1 Western Blots with only non-viral bands. In the afternoon, the committee will hear presentations, discuss and make recommendations on the topics of a history of hepatitis in blood and plasma donors and hepatitis B virus (HBV) nucleic acid testing. On March 17, the committee will hear updates on the following topics: summary of the January 2000 PHS advisory committee meeting on Blood Safety and Availability, CJD policy, HCV lookback guidance, post donation information algorithm, and IGIV clinical endpoints. In the morning, the committee will hear an informational presentation on the blood action plan: supply issues, and will discuss and make recommendations on donor deferral issues related to xenotransplantation. In the afternoon, the committee will be briefed on research programs in the Laboratory of Plasma Derivatives, Division of Hematology. The committee will also deliberate in closed session.

 

       
Location: Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products

Meeting Date: 9/16/99-9/17/99

Meeting Details:

On September 16, 1999 the following committee updates are tentatively scheduled: summary of the August 26-27,1999 meeting of the Public Health Service (PHS) advisory committee on Blood Safety and Availability; summary of the July 21, 1999 workshop on donor suitability: donor history of hepatitis; guidance document on revised precautionary measures to reduce the possible risk of transmission of Creutzfeldt-Jakob Disease (CJD) and new variant Creutzfeldt-Jakob Disease (nvCJD) by blood and blood products. Other committee updates will be scheduled if the need arises. In the morning the committee will hear and discuss an informational presentation on strategies for increasing the blood supply, and discuss and provide recommendations on nucleic acid testing of blood donors for human parvovirus B-19. In the afternoon, the committee will hear an information presentation on antigen/antibody testing for malaria. On September 17, 1999 the committee will sit as a medical device panel for the reclassification of Human Immunodeficiency Virus (HIV) drug sensitivity assays.

 

       
Location: Bethesda Ramada Inn Embassy Ballroom 8400 Wiscon Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products

Meeting Date: 6/17/99-6/18/99

Meeting Details:

On June 17, 1999, in the morning, the committee will discuss and provide recommendations on inadvertent contamination of plasma pools for fractionation: Risk issues. In the afternoon, the committee will discuss strategies for insuring compliance in the plasma fractionation industry, and the supply and demand of plasma derivatives. On June 18, 1999, the committee will hear informational presentations on the blood action plan and the device action plan, discuss and provide recommendations on the topic of deferral of blood donors at risk of malaria, and discuss and provide comments on the topic of HTLV supplemental tests. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: DoubleTree Hotel 1750 Rockville Pike Rockville, Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products

Meeting Date: 3/25/99-3/26/99

Meeting Details:

On March 25, 1999, in the morning, the Committee will hear, discuss, and provide comments on an informational presentation on Nucleic Acid Testing of Whole Blood. In the afternoon, the Committee will discuss and provide comments on Human Immunodeficiency Virus (HIV) p24 Antigen Testing and Validation of Donor History Questions. On March 26, 1999 the Committee will discuss and provide comment on an informational presentation on Clinical Trial Endpoints for Immune Globulin Intravenous (IGIV) and will discuss and provide recommendations on algorithms to address Inadvertent Contamination (with HIV, HBsAg, and/or HCV) of Plasma Pools for Fractionation.

 

       
Location: Bethesda Ramada Inn 8400 Wisconsin Avenue Bethes Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products

Meeting Date: 12/10/98-12/11/98

Meeting Details:

On December 10, 1998, the committee will hear updates on Hepatitis C Virus (HCV) Lookback Guidance, Malaria Deferral, and Supply Issues Regarding Plasma Derivatives. They will hear informational summaries on the Donor Suitability Workshop, the Pilot Program for Streamlining the Licensure of Blood and Blood Components Workshop, and discuss the topic of Hepatitis B Anti-Core (Anti-HBc) Re-entry. In the afternoon, the committee will discuss and provide recommendations on the End User Notification Initiatives for Plasma Derivatives. On December 11, the committee will discuss and provide recommendations on the topic of Inadvertent Contamination of Plasma Pools for Fractionation, and Recombinant B-Domain-Deleted Antihemophilic Factor, Sponsor: Genetics Institute.

 

       
Location: DoubleTree Hotel Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products

Meeting Date: 9/17/98-9/17/98

Meeting Details:

HCV Nucleic Acid Testing Year 2000 Computer Software Recent Review of Albumin Clinical Trials Summary of Cell Workshop Summary of Granulocyte Workshop Summary of HCV PCR Workshop TT Virus Transfusion Safety Abbott Laboratories PRISM Detetction Assay of HBsAg, Anti-HCV, and Anti-HTLV-I/II Routine Leukoreduction of Blood Components

 

       
Location: DoubleTree Hotel Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products

Meeting Date: 6/18/98-6/19/98

Meeting Details:

On June 18, the committe will hear updates on hepatitis C recipient notification and partner deferral of xenotransplantation recipients, and discuss information provided on the Blood Action Plan, Immune Globulin Intravenous supply issues, and Plasma Inventory Hold. In the afternoon, the Committee will discuss and make recommendations on standard testing for human immunodeficency virus (HIV) varaints. On June 19, the Committee will discuss and make recommendations on the review of clinical trail design for Alpha-1-Proteinase Inhibitor and, in the afternoon, review and discuss the draft report on the Hematology, and the Laboratories of Hepatitis and Molecular Virology, Division of Transfusion Transmitted Diseases.

 

       
Location: DoubleTree Hotel, Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products

Meeting Date: 3/24/98-3/24/98

Meeting Details:

The Committee will discuss Cepratea SC System, CellPro Incorporated, for use in processing autologous peripheral blood stem cells.

 

       
Location: DoubleTree Hotel, Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products

Meeting Date: 3/19/98-3/20/98

Meeting Details:

On March 19, 1998 the Committee will hear an informational summary of the emerginginfections plan of action and discuss and provide recommendations on the issue of the FDA proposal on plasma inventory hold. In the afternoon, the Committee will discuss the comparison of infectousdisease marker rates in paid versus volunteer donors. On March 20, 1998, the Committee will discuss and make recommendations on the issue of classification of blood bank software. In the afternoon, the Committee will discuss and make recommendations on the issue of relative safety of solven detergent-treated pooled plasma and single-donor plasma donor retested. The meeting will conclude with an informational presentation on the FDA proposal for donor deferrals related to xenotransplantation.

 

       
Location: DoubleTree Hotel, Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 12/12/96-12/12/96

Meeting Details:

On the morning of December 12, 1996, the committee will discuss the status of review of recombinant Factor IX, BeneFIX, Genetics Institutes, and review the FDA proposal on limiting plasma pool size for fractionated plasma products. In the afternoon, the committee will review issues of safety and efficacy concerning solvent detergent plasma, New York Blood Center. On the morning of December 13, 1996, the committee will review the status of HTLV-1/HTLV-II EIA, Abbott Laboratories, as in vitro dragnostic test kit to screen blood donors for the human tlymphotropic virus Types I and II, and the use of external controls with licensed infectious disease diagnostic test kits used for blood donor screening. In the afternoon, the committee will hear an informational report on the reinvention of the biologics license application (BLA) for blood products.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 9/26/96-9/26/96

Meeting Details:

On the morning of September 26, 1996, the committee will hear informational presentations on detection of the human immunodeficiency virus (HIV)-1 Group ``O'' and on the possible transmission of hepatitis C (HCV) by Immune Globulin. In the afternoon, the committee will review issues concerning recombinant Factor VIIa, Novo Nordisk. On September 27, 1996, the committee will sit as a Medical Device Panel to review and make recommendations on the reclassification of the Autopheresis-C System, a rotating membrane filtration blood separator, Fenwal Division, Baxter Healthcare Corp.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 3/21/96-3/21/96

Meeting Details:

On March 21, 1996, the committee will hear agency updates on Creutzfeldt-Jakob Disease and blood safety, peripheral blood hematopoietic stem cell products intended for transfusion, and a summary of regulatory issues related to human reproductive tissue. Labeling issues regarding testing for antibody to hepatitis C virus antigen by an ``HCV 3.0'' assay will be reviewed and discussed in the morning and in the afternoon, there will also be a discussion of clinical claims for the Roche Amplicor HIV Monitoring Test TM. On March 22, 1996, the committee will review and discuss implications of non-lipid enveloped viruses in blood products.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 12/14/95-12/15/95

Meeting Details:

On the morning of December 14, 1995, the committee will hear agency updates on Creutzfeldt-Jakob Disease and blood safety, and Human Immune Deficiency Virus, Type 1 (HIV-1) antigen screening of donors; review the report of the FDA/Health Resources Services Administration contract study of the Tissue Procurement and Distribution System in the United States, and hear scientific presentations on testing for Chagas disease (infection with Trypanosoma cruzi) in blood donors. In the afternoon, the committee will hear a summary of the Workshop on Cord Blood Derived Hematopoietic Stem Cells and presentation on Peripheral Blood Derived Hematopoietic Stem Cell Products Intended for Transfusion. A draft document for discussion concerning the application of current statutory authorities to peripheral blood hematopoietic stem cell products intended for transfusion will be made available. On the morning of December 15, 1995, the committee will review and make recommendations on issues related to respiratory syncytial virus immune globulin intravenous, MedImmune. In the afternoon, the committee will review and discuss the site visit reports of the Laboratories of Molecular Virology and Immunochemistry, Division of Transfusion Transmitted Diseases.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products

Meeting Date: 12/15/94-12/16/94

Meeting Details:

The committee will discuss involuntary collections from donors with Creutzfeldt-Jakob disease, collection of two units of red cells at a single donation Hepatitis C virus safety of immune globulins Nucleic acid assays for patient and drug monitoring in HIV.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products

Meeting Date: 6/22/94-6/22/94

Meeting Details:

On June 21, 1994, the committee will discuss and provide recommendations on plasma collected by apheresis, particularly with regard to infrequent donations of different frequencies, and on autologous blood donation, and in the afternoon, will discuss and provide recommendations on red cell loss during source plasma collection and plateletpheresis, and will hear an informational summary of regulatory issues concerning stem cells. The agenda for June 22, 1994, has not been developed. An amendment to this notice will be published in the Federal Register at a later date.

 

       
Location: Holiday Inn-- Gaithersburg, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 4/24/14-4/24/14

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Meeting Details:

On April 24, 2014, the committee will discuss the current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. FDA is convening this committee to seek clinical and scientific expert opinion on the risks and benefits of certain aversive conditioning devices based on available scientific data and information. The Agency is considering whether to ban aversive conditioning devices that are intended to administer a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. The meeting will concern only devices classified under 21 CFR 882.5235 (aversive conditioning device, class II) that are not self-administered. Devices which deliver a noxious electrical stimulus automatically are not considered to be self-administered devices. Section 516 of the FD&C Act (21 U.S.C. 360f) sets forth the standard for banning devices. Under that provision, in order to ban a device, FDA must make a finding that a device "presents substantial deception or an unreasonable and substantial risk of illness or injury" based on all available data and information. FDA regulations provide additional details about the procedures and standards for banning a device (21 CFR part 895).

 

       
Location: Holiday Inn - Main Ballroom 2 Montgomery Village Ave. Gaithersburg, MD 20879 Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 5/2/14-5/2/14

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Meeting Details:

The committee will discuss data submitted by MSD Consumer Care, Inc., to support a new drug application (NDA) 204804 for over-the-counter (OTC) marketing of montelukast 10 milligram (mg) tablets (proposed trade name SINGULAIR Allergy). The proposed OTC use is "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposes to label the product for OTC use in adults 18 years and older. Efficacy and safety data, as well as results of consumer studies, will be discussed. The committee will be asked to consider whether the data support an acceptable risk/benefit profile for the nonprescription use of montelukast tablets by OTC consumers.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 5/5/14-5/6/14

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Meeting Details:

On May 5-6, 2014, the Committee will meet to discuss methods for identifying the impact and increasing the reach of communications on topics of interest to consumers. The discussion will also address how FDA can evaluate whether its Consumer Updates (http://www.fda.gov/ForConsumers/ConsumerUpdates/default.htm disclaimer icon ) are reaching the targeted population, and whether they are increasing awareness and understanding of the key risk messages. The discussion will also assess whether the communications are having the intended impact on knowledge, behaviors and/or outcomes.

 

       
Location: The Great Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 5/6/14-5/7/14

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Meeting Details:

On May 6, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the RESQCPR System sponsored by Advanced Circulatory Systems, Inc. The RESQCPR System is comprised of two devices: the RESQPOD 16.0 Impedance Threshold Device, and the RESQPUMP Active Compression Decompression CPR Device. These devices are used together during manual cardiopulmonary resuscitation (CPR) in an attempt to enhance venous return to the heart and blood flow to vital organs during CPR to ultimately increase survival and neurologic outcome in patients suffering from out of hospital cardiac arrest. Advanced Circulatory Systems, Inc. has proposed the following indications for use: the RESQCPR System is intended for use in the performance of CPR to increase survival with favorable neurologic function in adult patients with non-traumatic cardiac arrest. On May 7, 2014, during session I, the committee will discuss and make recommendations regarding the classification of membrane lung for long-term pulmonary support systems, one of the remaining preamendment Class III devices regulated under the 510(k) pathway. A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). An ECMO procedure provides assisted extracorporeal circulation and physiologic gas exchange of a patient's blood when an acute (reversible) condition prevents the patient's own body from providing the physiologic gas exchange needed to sustain life. The circuit is comprised of multiple device types, including, but not limited to, an oxygenator, blood pump, cannulae, heat exchanger, tubing, filters, monitors/detectors, and other accessories; the circuit components and configuration (e.g., arteriovenous, veno-venous) may differ based on the needs of the individual patient or the condition being treated. ECMO is currently used for patients with acute reversible respiratory or cardiac failure, unresponsive to optimal ventilation and/or pharmacologic management.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 5/13/14-5/13/14

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Meeting Details:

On May 13, 2014, the committee will discuss and make recommendations regarding the guidance documents for contact lenses and contact lens accessories.

 

       
Location: Holiday Inn Germantown, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 6/17/14-6/17/14

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Meeting Details:

On June 17, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the Maestro® Rechargeable System sponsored by Enteromedics, Inc. The Maestro® Rechargeable System provides VBLOC Therapy. The implantable device is a neuromodulator, which delivers high frequency (5000 Hertz), controllable electrical pulses to the intra-abdominal vagus nerve trunks. The effect of VBLOC therapy is reported to suppress neural signals carried by the vagus nerve trunks, resulting in decreased hunger pangs, decreased digestive enzyme secretion and calorie absorption, and increased satiety. The device consists of implantable electronic device components that deliver VBLOC therapy, and external components that regulate device performance. The proposed indication for use for the Maestro® Rechargeable System, as stated in the PMA, is as follows: The Maestro® Rechargeable System is indicated for use in weight reduction in adult patients with obesity that have a Body Mass Index (BMI) of at least 40 kilograms per square meter (kg/m2), or a BMI of at least 35 kg/m2 with one or more obesity related comorbid conditions, and have failed a more conservative weight reduction alternative.

 

       
Location: FDA Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Adcomm

Meeting Date: 6/25/14-6/25/14

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Meeting Details:

he committee will discuss new drug application (NDA) 206162, olaparib capsules, application submitted by AstraZeneca Pharmaceuticals LP. The proposed indication (use) for this product is as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal) with germline BRCA mutation as detected by an FDA-approved test, who are in response (complete response or partial response) to platinum-based chemotherapy.

 

       
Location: FDA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drugs AdComm

Meeting Date: 4/22/14-4/22/14

Meeting Details:

The committee will discuss the safety and efficacy for new drug application 203077, MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, QRxPharma Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. This product represents the first drug combination consisting of two immediate-release opioids.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 4/21/14-4/21/14

Meeting Details:

On April 21, 2014, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107–109) and the Pediatric Research Equity Act (Pub. L. 108–155). The PAC will meet to discuss Activa Dystonia Therapy, ADVATE (antihemophilic factor (recombinant)), FAMVIR (famciclovir), INTELENCE (etravirine), KEPPRA (levetiracetam), MAXALT and MAXALT MLT (rizatriptan), NATAZIA (estradiol valerate and estradiol valerate/dienogest), PERTZYE (pancrelipase), PERZISTA (darunavir), REYATAZ (atazanavir), SKLICE (ivermectin), TISSEEL (fibrin sealant), TORISEL (temsirolimus), ULTRESA (pancrelipase), Vertical Expandable Prosthetic Titanium Rib (VEPTR), and VIREAD (tenofovir disoproxil fumarate).

 

       
Location: Bethesda Marriott 5151 Pooks Hill Road Bethesda, MD 20814 Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 4/1/14-4/1/14

Meeting Details:

The committee will discuss new drug application (NDA) 22-472, proposed trade name AFREZZA (TECHNOSPHERE Insulin Inhalation System), 3 unit and 6 unit cartridges for oral inhalation, manufactured by MannKind Corporation. The proposed indication (use) for this application is to improve glycemic control in adult patients with type 1 or type 2 diabetes mellitus.

 

       
Location: College Park Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 3/31/14-3/31/14

Meeting Details:

During the morning session, the committee will discuss new drug applications (NDAs) 205-435 and 205-436, tedizolid phosphate tablets and tedizolid phosphate injection, submitted by Trius Therapeutics, respectively, for the proposed indication of treatment of acute bacterial skin and skin structure infections. During the afternoon session, the committee will discuss NDA 021-883, dalbavancin hydrochloride for intravenous injection, submitted by Durata Therapeutics International B.V., for the proposed indication of treatment of acute bacterial skin and skin structure infections.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 3/27/14-3/27/14

Meeting Details:

The committee will discuss biologics license application 125468, serelaxin injection, submitted by Novartis, as a treatment to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMolecular and Clinical Genetics Panel

Meeting Date: 3/26/14-3/27/14

Meeting Details:

On March 26, 2014, the committee will discuss, make recommendations and vote on information related to the premarket approval application sponsored by Epigenomics, Inc. for the Epi proColon. The Epi proColon test is a qualitative in vitro diagnostic method for the detection of methylated Septin 9 DNA in plasma derived from patient whole blood specimens. Methylation of the target Septin 9 DNA sequence has been associated with the occurrence of colorectal cancer (CRC). The test is indicated to screen patients for CRC who are defined as average risk for CRC by current screening guidelines. The Epi proColon test is not intended to replace colorectal screening by colonoscopy. Patients with a positive Epi proColon test result should be referred for diagnostic colonoscopy. The Epi proColon test results are intended to be used in conjunction with the physician's assessment of history, other risk factors, and professional guidelines. On March 27, 2014, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Cologuard device, sponsored by Exact Sciences. Cologuard is an in vitro diagnostic device designed to analyze patients' stool for detection of hemoglobin, multiple DNA methylation and mutational markers, and the total amount of human DNA. Cologuard is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer or premalignant colorectal neoplasia. Cologuard is not intended as a replacement for colonoscopy. Cologuard is intended to be used in conjunction with colonoscopy and other test methods in accordance with recognized screening guidelines.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Past Meetings

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