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Vaccines, Blood & Biologics
Telecon, January 20, 2012 - HPC Cord Blood
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125391/0 Office: OCTGT
Hematopoietic Progenitor Cells,Cord (HPC-C)
Telecon Date/Time: 20-January-2012 1:00 PM Initiated by FDA? Yes
Telephone Number: -----(b)(4)------
Author: RAMANI SISTA
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Following introductions, FDA stated that cord blood banks can request exemption from bar code for their BLA applications. ClinImmune can use their ISBT-128 code as their barcode. The Sponsor will have to formally request this exemption. FDA has prepared a template for the exemption request which will be emailed to the Sponsor after the call. The Sponsor will have to add their information and formally submit to the application. The Sponsor agreed to include the exemption in their amendment 4, scheduled to be sent shortly.