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Vaccines, Blood & Biologics
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125391/0 Office: OCTGT
Hematopoietic Progenitor Cells,Cord (HPC-C)
Telecon Date/Time: 1-March-2012 2:00 PM Initiated by FDA? Yes
Telephone Number: 303-724-1307
Author: YONG FAN
Product – Thaw instruction
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body: FDA pointed out that the thawing instructions are not clear and difficult to follow. The applicant needs to revise the procedure and provide clear step by step instructions for cord blood units thaw, reconstitute and wash. ClinImmune agreed.