Telecon, May 7, 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: 07-May-2012 12:00 PM Initiated by FDA? Yes
Telephone Number: -----(b)(4)-----
Carton and Container Labeling
Author: RAMANI SISTA
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
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.