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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon, March 1, 2012 - HPC Cord Blood

 

RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA    Submission ID: 125391/0    Office: OCTGT
Product:
Hematopoietic Progenitor Cells,Cord (HPC-C)
Applicant:
Clinimmune Labs
Telecon Date/Time: 1-March-2012 2:00 PM        Initiated by FDA? Yes
Telephone Number: 303-724-1307
Communication Categorie(s):
Product
 
Author: YONG FAN
Telecon Summary:
Product – Thaw instruction
FDA PARTICIPANTS:
Yong Fan
 
NON-FDA PARTICIPANTS:
Linda Tapia
Sharon Miller
 
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.