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U.S. Department of Health and Human Services

About FDA

Public Workshop on Placental/Umbilical Cord Blood Products

Description: Hold Joint Public Workshop with OCTGT 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 allogenic 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a result of stakeholder input that occurred during the meeting, OCTGT/OCBQ are currently working toward finalizing the draft guidance “Investigational New Drug Application for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution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 DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Identify FDA planning committee and select OCBQ members

1/13/2010

Completed 11/24/2009

B. Finalize contract for workshop

2/12/2010

Completed 12/3/2009

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 2/2/2010

F. Finalize workshop agenda

2/6/2010

Completed 2/1/2010

G. Announce workshop on FDA website as a web notice

2/15/2010

Completed 1/27/2010

H. Draft OCBQ presentations

2/26/2010

Completed 2/26/2010

I. Finalize OCBQ 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 OCBQ

6/14/2010

Completed 6/4/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - 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.