Vaccines, Blood & Biologics
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Transcripts & Minutes (Biologics)
Information is arranged by topic, and within topic by date of the workshop or meeting, with the most recent event at the top of the list.
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General
Thermal Aspects of Radio Frequency Exposure, January 11-12, 2010 Prescription Drug User Fee Act Public Workshop (PDF - 435KB)11/14/2005 Workshop Strategies for Developing Therapeutics that Directly Target Anthrax and its Toxins; Public Workshop (PDF - 579KB)6/10/2004 Workshop Identifying Optimal Methods For Clinical Quantitative Flow Cytometry (PDF - 786KB)4/10-11/2003 Workshop Team Biologics Open Public Meeting (PDF - 148KB)5/21/2003 Meeting FDA Guidance on Clinical Trial Data Monitoring Committees (DMC's) Open Public Meeting (PDF - 394KB)11/27/2001 Meeting Plant-Derived Biologics Seminar and Public Hearing on Plant-Derived Biologics (PDF - 446KB)4/5-6/2000 Workshop Workshop on Development of Regulations and Guidance Documents for Medical Devices Regulated by the Center for Biologics Evaluation and Research (PDF - 146KB)11/15/1999 Workshop Draft Guidance for Industry Developing Medical Imaging - Open Public Meeting (PDF - 348KB)3/26/1999 Meeting Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License Public Workshop (PDF - 152KB)9/2/1998 Workshop
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Blood & Blood Products
Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components, Including Source Plasma Transcripts - Day 1 (PDF - 544KB)
9/15/2009 WorkshopPublic Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components, Including Source Plasma Transcripts - Day 2 (PDF - 745KB)
9/16/2009 WorkshopFDA Workshop to Consider Approaches to Reduce the Risk of Transfusion-Transmitted Babesiosis in the United States (PDF - 561KB)9/12/2008 Workshop Public Workshop: America's Blood Centers: Blood Establishment Computer Software (BECS) Conference (PDF - 591KB)7/10-11/2008 Workshop Public Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) (PDF - 909KB)4/29-30/2008 Workshop Workshop on Licensure of Apheresis Blood Products (PDF - 395KB)8/15/2007 Workshop FDA Workshop: Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing (PDF - 572KB)4/25-26/2007 Workshop Workshop on Molecular Methods in Immunohematology (PDF - 689KB)9/25-26/2006 Workshop FDA Workshop on Testing for Malarial Infections in Blood Donors (PDF - 423KB)7/12/2006 Workshop FDA Workshop on Behavior-Based Donor Deferrals in the NAT Era (PDF - 432KB)3/8/2006 Workshop Public Workshop - Biological Therapeutics for Rare Plasma Protein Disorders (PDF - 918KB)6/13/2005 Public Workshop - Update On: Leukocyte Reduction of Blood and Blood Components (PDF - 405KB)7/20/2005 Workshop Workshop on Intravenous Immune Globulins in the 21st Century: Progress and Challenges in Efficacy, Safety, and Paths to Licensure (PDF - 388KB)4/13/2005 Workshop Workshop on Plasma Standards (PDF - 456KB)8/31/2004 Workshop Workshop on Use of Radiolabeled Platelets for Assessment of In Vivo Viability of Platelet Products (PDF - 402KB)11/21/2003 Workshop Workshop on Factor VIII Inhibitors (PDF - 441KB)11/21/2003 Workshop Workshop on Development of Donor Screening Assays for West Nile Virus (PDF - 1MB)11/4-5/2002 Workshop Safety and Efficacy of Methods for Reducing Pathogens in Cellular Blood Products Used in Transfusion (PDF - 1022KB)8/7-8/2002 Workshop Comparability Studies for Human Plasma-Derived Therapeutics Workshop (PDF - 537KB)5/30-31/2002 Workshop Best Practices for Reducing Transfusion Errors - OBRR/CBER/FDA Workshop (PDF - 598KB)2/14/2002 Workshop Application of Nucleic Acid Testing to Blood Borne Pathogens and Emerging Technologies OBRR/CBER/FDA Workshop (PDF - 945KB)12/4-5/2001 Workshop on Streamlining the Blood Donor History Questionnaire (PDF - 399KB)10/16/2000 Workshop Workshop on Recruiting Blood Donors - Successful Practices (PDF - 489KB)7/6-7/2000 Workshop Workshop on Implementation of Nucleic Acid Testing (PDF - 401KB)12/14/1999 Workshop Workshop on Implementation of Universal Leukoreduction (PDF - 408KB)12/10/1999 Workshop Workshop on Blood Donor Suitability (PDF - 465KB)12/9/1999 Workshop Workshop on Standards for Inactivation and Clearance of Infectious Agents in the Manufacture of Plasma Derivatives From Non-Human Source Materials for Human Injectable Use (PDF - 305KB)10/25/1999 Workshop Workshop on Plasticizers: Scientific Issues in Blood Collection, Storage & Transfusion (PDF - 509KB)10/18/1999 Workshop Workshop on Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics and Red Cell Substitutes (PDF - 649KB)10/18/1999 Workshop Workshop on Bacterial Contamination of Platelets (PDF - 446KB)9/24/1999 Workshop Blood Donor Suitability Workshop: Donor History of Hepatitis (PDF - 361KB)7/21/1999 Workshop Pilot Program for Streamlining the Licensure of Blood and Blood Components (PDF - 283KB)12/9/1998 Workshop Medical Device Action Plan - Open Public Meeting (PDF - 175KB)12/1/1998 Meeting Blood Donor Suitability Workshop (PDF - 456KB)11/23/1998 Workshop Evaluation of In Vivo Efficacy of Platelet Transfusion Products and Platelet Substitutes (PDF - 388KB)9/28/1998 Workshop Nucleic Acid Testing for HCV and Other Viruses in Blood Donors (PDF - 393KB)9/16/1998 Workshop Granulocytes for Transfusion: Research and Clinical Experience (PDF - 390KB)9/11/1998 Workshop Potency and Dosage of von Willebrand Factor Concentrates (PDF - 387KB)9/26/1997 Workshop Current Topics in Immunohematologic Testing (PDF - 372KB)12/10/1997 Workshop Biologics License Application (BLA) for Blood Products and Reporting Changes to (PDF - 292KB)12/2/1997 Workshop
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Cellular & Gene Therapy
FDA/NIST Sponsored Workshop - In Vitro Analyses of Cell/Scaffold Products (PDF - 1007KB)12/6-7/2007 Workshop Meeting and Public Workshop On Safety Issues Pertaining to the Clinical Application of Flow Cytometry to Human-Derived Cells (PDF - 359KB)4/20/2001 Workshop Adenoviral Vector Safety Public Meeting and Workshop (PDF - 125KB)2/1/2001 Workshop Proceedings of FORUM 96: Gene Therapy (PDF - 679KB)7/11-12/1996 Workshop
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Tissue & Tissue Products
FDA Public Workshop: Processing of Orthopedic, Cardiovascular, and Skin Allografts (PDF - 733KB)10/11-12/2007 Workshop Workshop on Evidence Based Assisted Reproductive Technologies (ART) (PDF - 772KB)9/18-19/2002 Workshop Tissue Reference Group Progress Workshop (PDF - 79KB)8/29/2001 Workshop Workshop: Unrelated Allogeneic Cord Blood Banking and Transplant Forum (PDF - 772KB)8/14-15/2000 Workshop Open Public Meeting: Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopedic Reconstruction and Repair (PDF - 343KB)8/2/2000 Meeting Hematopoietic Stem/Progenitor Cell Products: Discussion of Unrelated Allogeneic Placental/Umbilical Cord Blood and Peripheral Blood Cell Banking and Transplantation (PDF - 491KB)9/10/1998 Workshop
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Vaccines
Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development (PDF - 831KB)12/10-11/2007 Workshop Anthrax Vaccines: Bridging Correlates Of Protection In Animals To Immunogenicity In Humans (PDF - 870KB)11/8-9/2007 Workshop Public Workshop on Animal Models and Correlates of Protection for Plague Vaccines (PDF - 595KB)10/13-14/2004 Workshop Workshop on Non-Clinical Safety Evaluation of Preventive Vaccines: Recent Advances and Regulatory Considerations (PDF - 897KB)12/2/2002 Workshop Anthrax Vaccines: Efficacy Testing and Surrogate Markers of Immunity Workshop (PDF - 275KB)4/23/2002 Workshop Workshop on Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development (PDF - 5.6MB)9/7-10/1999 FDA-NCI Workshop on Tumor Vaccines (PDF - 926KB)12/10-11/1998 Workshop Simian Virus 40: A Possible Human Polyomavirus Workshop (PDF - 1.1MB)1/27-28/1997 Workshop
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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