Workshops & Open Public Meetings
2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996
Information is arranged by date of the workshop or meeting, with the most recent event at the top of the list.
Public Workshop: Improving Endpoints, Improving Care: Alpha-1 Antitrypsin Augmentation Therapy and Clinical Trials (PDF - 1.4 MB) - 3/23-24/2009
Public Workshop: Adjuvants and Adjuvanted Preventative and Therapeutic Vaccines for Infectious Disease Indications - 12/2-12/3/2008
December 2, 2008 Transcripts (PDF - 3 MB)
December 3, 2008 Transcripts (PDF - 1 MB)
Public Workshop: America's Blood Centers: Blood Establishment Computer Software (BECS) Conference - 7/10-11/2008
Public Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) - 4/29-30/2008
Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development - 12/10-11/2007
FDA/NIST Sponsored Workshop - In Vitro Analyses of Cell/Scaffold Products - 12/6-7/2007
Anthrax Vaccines: Bridging Correlates Of Protection In Animals To Immunogenicity In Humans - 11/8-9/2007
November 8, 2007 Transcripts
November 9, 2007 Transcripts
FDA Public Workshop: Processing of Orthopedic, Cardiovascular, and Skin Allografts - 10/11-12/2007
October 11, 2007 Transcripts
October 12, 2007 Transcripts
Workshop on Licensure of Apheresis Blood Products - 8/15/2007
FDA Workshop: Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing - 4/25-26/2007
4/25/2007 Transcript
4/26/2007 Transcript
Workshop on Molecular Methods in Immunohematology - 9/25-26/2006
9/25/2006 Transcript
9/26/2006 Transcript
FDA Workshop on Testing for Malarial Infections in Blood Donors - 7/12/2006
FDA Workshop on Behavior-Based Donor Deferrals in the NAT Era - 3/8/2006
Prescription Drug User Fee Act Public Meeting - 11/14/2005
Public Workshop - Biological Therapeutics for Rare Plasma Protein Disorders - 6/13-14/2005
Public Workshop - Update On: Leukocyte Reduction of Blood and Blood Components - 7/20/2005
Workshop on Intravenous Immune Globulins in the 21st Century: Progress and Challenges in Efficacy, Safety, and Paths to Licensure - 4/13/2005 - (PDF), (Text)
Public Workshop on Animal Models and Correlates of Protection for Plague Vaccines- 10/13 - 14/2004
Workshop on Plasma Standards- 8/31/2004 & 9/1/2004
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FEDERAL REGISTER Establishing a Docket for the Development of Plasma Standards Public Workshop; Notice - 1/3/2005 -
(PDF),
(Text)
Strategies for Developing Therapeutics that Directly Target Anthrax and its Toxins; Public Workshop - 6/10/2004 - (471 pages) - (PDF), (Text)
Workshop on Use of Radiolabeled Platelets for Assessment of In Vivo Viability of Platelet Products - 5/3/2004 - (357 pages) - (PDF), (Text)
Workshop on Factor VIII Inhibitors - 11/21/2003 - (352 pages) - (PDF), (Text)
Identifying Optimal Methods For Clinical Quantitative Flow Cytometry - 4/10 - 11/2003
Team Biologics Open Public Meeting - 5/21/2003 - (96 pages) - (PDF), (Text)
Workshop on Non-Clinical Safety Evaluation of Preventive Vaccines: Recent Advances and Regulatory Considerations - 12/2-3/2002
Workshop on Development of Donor Screening Assays for West Nile Virus - 11/4-5/2002
Workshop on Evidence Based Assisted Reproductive Technologies (ART) - 9/18-19/2002
Safety and Efficacy of Methods for Reducing Pathogens in Cellular Blood Products Used in Transfusion - 8/7-8/2002
Comparability Studies for Human Plasma-Derived Therapeutics Workshop - 5/30-31/2002
Anthrax Vaccines: Efficacy Testing and Surrogate Markers of Immunity Workshop - 4/23/2002 - (264 pages) - (PDF), (Text)
Best Practices for Reducing Transfusion Errors - OBRR/CBER/FDA Workshop - 2/14-15/2002
Application of Nucleic Acid Testing to Blood Borne Pathogens and Emerging Technologies OBRR/CBER/FDA Workshop - 12/4-5/2001
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12/4 - Part 1 -
(PDF),
(Text);
Part 2 -
(PDF)
(Text)
12/5 - Part 1 - (PDF), (Text); Part 2 - (PDF), (Text)
FDA Guidance on Clinical Trial Data Monitoring Committees (DMC's) Open Public Meeting - 11/27/2001
Tissue Reference Group Progress Workshop - 8/29/2001 - (61 pages) - (PDF)
Meeting and Public Workshop On Safety Issues Pertaining to the Clinical Application of Flow Cytometry to Human-Derived Cells - 4/20/2001
Adenoviral Vector Safety Public Meeting and Workshop - 2/1/2001 - (83 Pages) - (PDF), (Text)
Workshop on Streamlining the Blood Donor History Questionnaire - 10/16/2000 - (327 Pages) - (PDF), (Text)
Workshop: Unrelated Allogeneic Cord Blood Banking and Transplant Forum - 8/14-15/2000
Open Public Meeting: Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopedic Reconstruction and Repair - 8/2/2000 - (PDF)
Workshop on Recruiting Blood Donors - Successful Practices - 7/6-7/2000
Plant-Derived Biologics Seminar and Public Hearing on Plant-Derived Biologics - 4/5-6/2000
Workshop on Implementation of Nucleic Acid Testing - 12/14/1999 - (285 pages) - (PDF)
Workshop on Implementation of Universal Leukoreduction - 12/10/1999 - (263 pages) - (PDF), (Text)
Workshop on Blood Donor Suitability - 12/9/1999 - (308 pages) - (PDF), (Text)
Workshop on Development of Regulations and Guidance Documents for Medical Devices Regulated by the Center for Biologics Evaluation and Research - 11/15/1999 - (99 pages) - (PDF), (Text)
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 - 10/25/1999 - (199 pages) - (PDF), (Text)
Workshop on Plasticizers: Scientific Issues in Blood Collection, Storage & Transfusion - 10/18/1999
Workshop on Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics and Red Cell Substitutes - 9/27-28/1999
Workshop on Bacterial Contamination of Platelets - 9/24/1999 - (292 pages) - (PDF)
Workshop on Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development - 9/7-10/1999 -
-
A Defined-Risks Approach to the Regulatory Assessment of the Use of Neoplastic Cells as Substrates for Viral Vaccine Manufacture -
(PDF)
9/7 - (87 Pages) - (Text)
9/8 - (316 Pages) - (Text)
9/9 - (399 Pages) - (Text)
9/10 - (259 Pages) - (Text)
Blood Donor Suitability Workshop: Donor History of Hepatitis - 7/21/1999 - (243 Pages) - (PDF), (Text)
Draft Guidance for Industry Developing Medical Imaging - Open Public Meeting - 3/26/1999 - (PDF), (Text)
FDA-NCI Workshop on Tumor Vaccines - 12/10-11/1998
Pilot Program for Streamlining the Licensure of Blood and Blood Components - 12/9/1998 - (216 pages) - (PDF), (Text)
Medical Device Action Plan - Open Public Meeting - 12/1/1998 - (PDF)
Blood Donor Suitability Workshop - 11/23/1998 - (303 pages) - (PDF)
Evaluation of In Vivo Efficacy of Platelet Transfusion Products and Platelet Substitutes - 9/28/1998 - (265 pages) - (PDF), (Text)
Nucleic Acid Testing for HCV and Other Viruses in Blood Donors - 9/16/1998 - (280 pages) - (PDF), (Text)
Granulocytes for Transfusion: Research and Clinical Experience - 9/11/1998 - (258 pages) - (PDF), (Text)
Hematopoietic Stem/Progenitor Cell Products: Discussion of Unrelated Allogeneic Placental/Umbilical Cord Blood and Peripheral Blood Cell Banking and Transplantation - 9/10/1998 - (346 pages) - (PDF)
Developing U.S. Public Health Policy in Xenotransplantation - 1/21/1998
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Transcripts available from FDA Dockets in RTF and PDF formats
Potency and Dosage of von Willebrand Factor Concentrates - 9/26/1997 - (274 pages) - (PDF)
Current Topics in Immunohematologic Testing - 12/10/1997 - (291 pages) - (PDF)
Biologics License Application (BLA) for Blood Products and Reporting Changes to an Approved Application - 12/2/1997 - (232 pages) - (PDF)
Simian Virus 40: A Possible Human Polyomavirus Workshop - 1/27-28/1997
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1/27 - Part 1, (170 pages); Part 2, (173 pages)
1/28 - (351 pages)
Bibliography (7 pages)
List of participants(26 pages)
List of speakers(4 pages)
Proceedings of FORUM 96: Gene Therapy - 7/1996 - (PDF), (Text)
FDA and the Internet: Advertising and Promotion of Medical Products - 10/1996