Tissue Minutes / Summaries / Transcripts
Scientific / Regulatory Information Meetings
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FDA Public Workshop: Processing of Orthopedic, Cardiovascular, and Skin Allografts - 10/11-12/2007
American Association of Tissue Banks Annual Meeting - 9/17/2007
- FDA Update: Relevant to Reproductive Establishments - Martha A. Wells, MPH, RAC
- FDA Update - Melissa Greenwald, M.D.
Joint Commission Resources - Strategies for Transplantation Safety and Quality - 8/29/2007 & 9/6/2007
- U.S. Food and Drug Administration Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products (HCT/Ps) - Laura M. St. Martin, M.D., M.P.H. & Celia M. Witten, Ph.D., M.D.
American Association of Bioanalysts Annual Meeting - 5/17/2007
- FDA Update: Relevant to Reproductive Establishments - Martha A. Wells, MPH, RAC
- Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Martha A. Wells, MPH, RA
AATB 11th Annual Spring Meeting - 3/27/2007
- FDA Update - Melissa Greenwald, M.D.
ASBMT/CIBMTR BMT Tandem Meetings - 2/11/2007
- Regulatory Issues Session - Ellen Lazarus, MD, FCAP
3rd Annual FDA and the Changing Paradigm for HCT/P Regulation - 1/24/2007
- FDA HCT/P Inspection Experience: Analysis by Area and General Update - Mary Malarkey
- Quality Program, CAPA and Audits - Mary Malarkey
- FDA Update - Martha A Wells, MPH
- Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Tested For Communicable Diseases Using Pooled Specimens or Diagnostic Tests - Martha A Wells, MPH
- Regulatory Pathways: What Regulations Apply - Ruth Solomon, M.D.
American Association of Blood Banks Annual Meeting - 10/23-25/2006
- Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products Division of Human Tissues Update - Ellen Lazarus, MD, FCAP
American Society for Reproductive Medicine Annual Meeting - 10/22-26/2006
- FDA Update: Regulation of Reproductive Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) - Jackie Neidinger, BS, CTBS
AATB Annual Meeting - 9/9-12/2006
- FDA Update - Ruth Solomon, M.D.
- FDA Update: Regulation of Reproductive Establishments - Martha A Wells, MPH
- FDA Adverse Reaction Reporting System for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) - Laura M. St. Martin, M.D., M.P.H.
WHO Meeting - 6/7-9/2006
- FDA and Tissue Regulation - Celia Witten, Ph.D., M.D.
- FDA Inspections Tissue/Cell Establishments - Martha A Wells, MPH
- FDA Adverse Reaction Reporting System for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) - Martha A Wells, MPH
America's Blood Centers Meeting - 3/4/2006
- Testing Donors of Human Cell and Tissues - Melissa A. Greenwald, MD
2nd Annual FDA and the Changing Paradigm for Tissue Regulation - 2/7/2006
- Overview: GMP, GTP and QS Regulation - Mary Malarkey
- Then and Now: Update on the GTPs for HCT/Ps - Mary Malarkey
- Testing Donors of Human Cells and Tissues - Melissa A. Greenwald, MD
- Reporting HCT/P Deviations - Anita Richardson
- FDA Regulatory Pathway - Ellen Lazarus, M.D.
- Reporting HCT/P Adverse Reactions - Su Wang Chen, MD MPH
Workshop on Evidence Based Assisted Reproductive Technologies (ART) - 9/18-19/2002
FDA's Tissue Reference Group Workshop - Washington, DC - 8/29/2001
- Transcript (61 pages) - (PDF)
FDA / EBAA Meeting Regarding Current Good Tissue Practice Issues - 5/3/2001
- Minutes - (Text)
FDA / ASRM Meeting Regarding Current Good Tissue Practice Issues - 4/16/2001
- Minutes (Text)
Unrelated Allogeneic Cord Blood Banking and Transplant Forum - 8/14-15/2000
- Unrelated Allogeneic Cord Blood Banking Transplantation Forum: Summary - Ellen F. Lazarus, M.D.
- Transcript
08/14/2000 (282 pages) (PDF), (Text)
08/15/2000 (242 pages) (PDF), (Text)
Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopedic Reconstruction and Repair - 8/2/2000
- "Overview of Relevant Comments to the Proposed Rules Dockets Concerning Regulation of Bone Products" - Marty Wells, MPH
- "Overview of the History of FDA Regulation of Bone as a Tissue" - Antonio Pereira, M.D.
- "Overview of the History of FDA Regulation of Devices made From Bone" - Aric Kaiser, MS
- "Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopedic Reconstruction" - Ruth Solomon, M.D.
- "Human Bone Allograft: Summary" - Ruth Solomon, M.D.
- Transcript
FDA / ASRM Meeting Concerning the Donor Suitability Proposed Regulation - 2/10/2000
Workshop: Hematopoietic Stem / Progenitor Cell Products: Discussion of Unrelated Allogenic / Umbilical Cord Blood and Peripheral Blood Cell Banking and Transplantation - 9/10/1998
FDA / AATB Meeting Concerning Summary of Records - 4/20/1998
FDA / AATB Meeting Concerning Demineralized Bone - 7/11/1997
FDA Open Public Meeting on the Proposed Approach - 3/17/1997