About FDA
Public Workshop on Placental/Umbilical Cord Blood Products
Description: Hold Joint Public Workshop with OCBQ on Placental/Umbilical Cord Blood Products with American Association of Blood Banks (AABB). CBER and AABB are collaborating to present: Cord Blood Licensure - A Workshop. The purpose of the workshop is to provide an educational opportunity for potential stakeholders such as cord blood banks, registries, individual physicians, and other stakeholders to learn about the pathway to licensure or investigational new drug (IND) submission for minimally manipulated allogeneic unrelated cord blood for specified indications.
Accomplishment: On March 8 and 9, 2010, CBER conducted a workshop to provide an educational opportunity for cord blood banks, registries, and other stakeholders to learn about the pathway to licensure or Investigational New Drug (IND) submission for minimally manipulated allogeneic cord blood for specified indications. As a result of stakeholder input that occurred during the meeting, OCTGT/OCBQ are currently working toward finalizing the draft guidance “Investigational New Drug Application for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for specified Indications”. Additionally, stakeholder input assisted OCTGT/OCBQ in addressing items in a CBER-sponsored 2-day Cord Blood training course for CBER and Office of Regulatory Affairs (ORA) staff, as well as updating the Compliance Program Guidance Manual (7345.848) to include Cord Blood Products.
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
A. Identify FDA planning committee and select OCTGT members |
1/13/2010 |
Completed | 11/24/2009 |
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B. Finalize contract for workshop |
2/12/2010 |
Completed | 12/3/2009 |
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C. Draft workshop agenda |
2/12/2010 |
Completed | 12/4/2009 |
|
D. Establish schedule and process for joint FDA-AABB planning meetings |
2/12/2010 |
Completed | 12/4/2009 |
|
E. Confirm workshop speakers |
2/3/2010 |
Completed | 12/2/2010 |
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F. Finalize workshop agenda |
2/6/2010 |
Completed | 2/1/2010 |
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G. Announce workshop on FDA website as a web notice |
2/15/2010 |
Completed | 1/27/2010 |
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H. Draft OCTGT presentations |
2/26/2010 |
Completed | 2/26/2010 |
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I. Finalize OCTGT presentations |
3/5/2010 |
Completed | 3/5/2010 |
|
J. Hold Joint Public Workshop |
3/8-9/2010 |
Completed | 3/8-9/2010 |
|
K. Evaluate workshop to determine next steps for OCTGT |
6/14/2010 |
Completed | 6/4/2010 |
Key Projects Legend
| Milestone Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |
Glossary
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.
