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FDA Alerted of Bovine Brain Material in Collagenase Enzymes
Click here for information.
Circular of Information: For the use of Cellular Therapy Products
This circular was prepared jointly by the American Association of Blood Banks, America’s Blood Centers, American Red Cross, American Society for Blood and Marrow Transplantation, International Society for Cellular Therapy, Foundation for the Accreditation of Cellular Therapy, and National Marrow Donor Program. Federal law prohibits dispensing the cellular therapy products describe in this circular without a prescription.
To access the complete Circular of Information, please click here.
Somatic Cell Therapy Symposium: Scenarios
GTP Implementation:
Scenario 1: Environmental Monitoring/Facility
Scenario 2: Environmental Monitoring/Facility
Scenario 3: Urgent Medical Need
Scenario 4: Urgent Medical Need
Scenario 5: Microbiology Laboratory Registration
Scenario 6: Donor Records
Problem Management:
Scenario 1:(File Attached: Problem Mgt Scenario #1)
Scenario 2: (File Attached: Problem Mgt Scenario #2)
Scenario 3:(File Attached: Problem Mgt Scenario #3)
Scenario 4:(File Attached: Problem Mgt Scenario #4)
Reporting:
Scenario 1:(File Attached: Reporting Scenario #1)
Scenario 2:(File Attached: Reporting Scenario #2)
Scenario 3:(File Attached: Reporting Scenario #3)
Scenario 4:(File Attached: Reporting Scenario #4)
Scenario 5:(File Attached: Reporting Scenario #5)
Scenario 6: (File Attached: Reporting Scenario #6)
Storage and Cryopreservation of Cell Products
Table of Contents
1. Cryopreservation, Storage and Shipment
2. Sample Generic Cryopreservation Procedure
a. DMSO Freeze Solution
b. DMSO (Neat)
c. DMSO/Pentastarch
3. General Issues in Storage and Inventory
4. Sample Thawing Procedures
a. Thawing and Infusion Bedside
b. Thawing in the Laboratory
5. References
AUDIOCONFERENCE SERIES
Facility Sanitization Conference Call Summary: November 12, 2003
PDF SUMMARY
Processing and Infusion Issues of ABO Incompatible Hematopoietic Progenitor Cell-Apheresis Products
Conference Call Summary: March 24, 2004
PDF SUMMARY
Links
Regulations:
CDC Travel (Alerts etc for Donor Evaluation)
The Center for Biologics Evaluation and Research (CBER)
CBER Forms
CLIA Regulations
CLIA Test Database
Clinical Laboratory Improvement Amendments
Code of Federal Regulations Search
Food and Drug Administration (FDA)
FDA Approved Donor Tests
Registered Establishment Query
Regulatory Process References
Tissue Related Documents
Canadian GMPs
EU GMPs
EU Cell and Tissue Regulations
Human Tissue Authority-UK
For Patients:
National Cancer Institute
National Heart Lung and Blood Institute
National Marrow Donor Program
NCI Cancer Trials Database
NIH Library and Literature Resources
NIH Clinical Trials Database
A Parent’s Guide to Cord Blood Banks
Other Societies:
American Association of Blood Banks (AABB)
American Association of Tissue Banks (AATB)
American Society For Apheresis (ASFA)
American Society for Blood and Marrow Transplantation (ASBMT)
American Society for Histocompatibility and Immunogenetics (ASHI)
Assistance for Cellular Therapy (PACT) Group
California Blood Bank Society
Cell Transplant Society
College of American Pathologists (CAP)
Foundation for the Accreditation of Cellular Therapy (FACT)
ICCBA - ISBT 128 labeling
International Organization for Standardization (IOS)
International Pancreas and Islet Transplant Association (IPITA)
National Marrow Donor Program (NMDP)
NETCORD
Tissue Engineering and Regenerative Medicine International Society (TERMIS)
United States Pharmacopeia (USP)
Tools:
NCI Common Toxicity Criteria
Statistics Panacaea
Statistics: British Medical Journal
Statistics: The Little Handbook of Statistical Practice
Statistics: Vassar Stats
Taxonomic Key Program
World Clock
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