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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon, May 7, 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: 07-May-2012  12:00 PM        Initiated by FDA? Yes
Telephone Number: -----(b)(4)-----
Communication Categorie(s):
Carton and Container Labeling
 
Author: RAMANI SISTA
Telecon Summary:
Labeling
FDA PARTICIPANTS:
Ramani Sista
Yong Fan
Kim Benton
Loan Nguyen
 
NON-FDA PARTICIPANTS:
Brian Freed
Sabine Stockinger
Linda Tapia
Michael Aubrey
Sharon Miller
Stephanie Warnell
-------(b)(4)------
 
Trans-BLA Group: No
 Related STNs: None
Related PMCs: None
 
Telecon Body
Following introductions the sponsor was referred to the label inserted on the cartridge\canister. APLB asked if some of the information on the label such as the cryopreservation date was necessary since FDA did not require it. The sponsor stated that including cryopreservation information was a requirement by AABB organization. FDA asked if there was any requirement of placement of information on the label, to which the sponsor stated there was not. APLB stated that they would like to rearrange the information on the label for clarity and to reduce medication errors. The sponsor stated that while they cannot delete information, it is acceptable to move it around for clarity. The sponsor was advised on the information that needed rearranging on the label. The sponsor agreed to make the changes and submit to the file.
 

The sponsor requested some clarifications regarding the package insert which were answered by APLB.