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Home    September 3, 2010
 
 

Advancing Transfusion and Cellular Therapies Worldwide (AABB) American Society for Blood and Marrow Transplantation (ASBMT) Food and Drug Administration (FDA) Foundation for the Accreditation of Cellular Therapy (FACT) Health Resources and Services Administration (HRSA)   Netcord - Unique Source for Stem Cells National Marrow Donor Program (NMDP)

 
 

 

FDA Docket
AABB has submitted to the federal docket questions raised last month . . .
More...
 AABB Annual Meeting
AABB Annual Meeting & CTTXPO 2010 in Baltimore, Maryland . . .
More...
 
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Welcome to the newly created
Cord Blood Licensure Workshop website!

This website was created to support the volunteer working groups formed at the Cord Blood Licensure Workshop on March 10, 2010.  The contents of the site are the result of collaborative efforts to facilitate the process of obtaining a Biologics License Application.  The documents provided are formatted as templates, useful in permitting colleagues in the industry to customize them according to their needs.  The website also serves to assemble links to actions and developments related specifically to licensure.

Meeting summaries and products developed through the work of these groups will be posted by the group leader.   These documents may be accessed by clicking the appropriate link in the Working Group Directory below.

For questions concerning the content on this site please contact us via email support@transtem.com

 
 

Terms and Limitations of Use: 

This website was developed as a resource for members of partnering organizations who are pursuing licensure.  The contents of this site and the documents that appear here are intended as guidance only.  Use of the documents does not guarantee compliance with standards or regulations.  Use by media or parties outside of the member organizations is prohibited without permission.

   
Disclaimer: 

Organizations represented on this page refer to those who served on the Workshop’s Planning Committee.  The appearance of their logos does not imply their endorsement of the documents that appear here.

 

 
 

Related Documents

 
 
 
Working Groups Directory
 
WORKING GROUPS LEADER
Consent Issues (Mom) Kathleen Sazama
Sterility John McMannis
Vendor Qualification Sue Armitage
Potency and Release Joanne Kurtzberg
Thaw and Administration Kathy Welte
Transportation and Shipping Fran Rabe
Post BMT Doug Rizzo
Adverse Event Investigation John Miller
Labeling Becky Haley
Expiration Dates/Stability Kathy Fortune

 

 
 

 

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