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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, May 23, 2013 - HPC, Cord Blood BLA 125432

 

Product:HPC, Cord Blood
Applicant:LifeSouth Community Blood Centers, Inc.
Telecon Date/Time: 23-May-2013 10:00 AM        Initiated by FDA? Yes
Telephone Number: Telephone Number: -------------------(b)(4)--------------------------
 
Communication Categorie(s):1. Other - Package and container label discussion
 
Author: CANDACE JARVIS
Telecon Summary: This meeting was requested by FDA to discuss the package and container labels
FDA Participants: Mohammad Heidaran, Ph.D., Biologist (CBER/OCTGT/DCGT)
      Eric Dollins, Ph.D., Biologist (CBER/OCTGT/DCGT)     
      Safa Karandish, B.S. MT (ASCP). CSO (CBER/OCTGT/DHT)
      Candace Jarvis, B.S., CSO (CBER/OCTGT/RMS)
      Kimberly Benton, Ph.D., Deputy Director (CBER/OCTGT/DCGT)
      Karoll Cortez, Ph.D., Medical Officer (CBER/OCTGT/DHT)
      Loan Nguyen, Ph.D, Reviewer (CBER/APLB)
 
Non-FDA Participants: Jill Evans, Vice President of Quality
                                     Evan Basler
                                     Ed Downey
                                     Dan Simpson
 
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:FDA requested a brief teleconference with LifeSouth to discuss the package and container labels for the CB units. An email was sent to LifeSouth on May 20, 2013 with an example of what the labels should contain (See below):
The applicant responded back to my email on May 21, 2013 and stated that our requested changes for the container label were being made; however, they needed some clarification on the changes requested for the package label and sent the following:
  • Our label includes “For Intravenous Administration.”  Is this acceptable or do you require the specific wording “For Intravenous Infusion”?
  • Currently, “Rx only” appears in the upper left quadrant (in accordance with ISBT128 standards) – changing the location, if needed, would involve software revision by the manufacturer.
  •  “Buffy coat enriched” is an attribute associated with the product code but can be removed if necessary (without manufacturer intervention).
  • Our label includes a statement “See Package Insert for full prescribing information.”  Adding extra verbiage to this statement may be a space issue.
  • We can change the list of additives/residuals but changing the location (to below the unit volume) may also pose a space issue.
 
Container Label:
 
1)Manufacturer information should be grouped together. Consider presenting all manufacturer information on one side of the label and the product code on the other side.
 
Discussion: LifeSouth agreed
 
2)Present the name of the product, “HPC, Cord Blood,” in a separate line from the term “Cryopreserved”. For example,
Cryopreserved
HPC, Cord Blood
 
Discussion: LifeSouth agreed
3) If there is a 4 line limitation for the bottom portion of the label, the storage temperature may be moved up to the side of the label that has the product code.
 
4)    If you do not have room for full list of additives please delete the line "10% DMSO, Other Additive Present".
 
Discussion: LifeSouth agreed with the suggested changes. They said they will look into either adding a full list of additive and if not they will remove the additives.
 
Package Label:
 
1) Delete the manufacturer information from the top left quadrant since it is already in the lower right quadrant.
 
Discussion: The applicant said that this may not be possible. They have to check into the software capability and get back to us. The sponsor also noted that what the agency is requesting appears to be inconsistent with ISBT in the US consensus document. FDA states that they will review the document and get back in touch with them.
 
2) Present the license number with the manufacturer information.
 
Discussion: The applicant stated that they are unsure if the software will allow them to put the license number with the manufacturing number as only certain information can be moved. 
 
3) Add the route of administration “For Intravenous Infusion” and move the statement “Rx only” to the lower left quadrant.
 
Discussion: The applicant asked if it was okay to use “For Intravenous Administration” instead of “For Intravenous Infusion” as this is common terminology with the software they have. FDA stated that for consistency, they would prefer that that “For Intravenous Infusion” be used; however, this can be taken into consideration as being optional and asked that the sponsor send this in with their response.
 
4) Clarify if the term “buffy coated enriched” is needed. Other licensed cord blood products do not have this description.
 
Discussion: The applicant stated that “buffy coated enriched” was placed on the label because of the product code listing and it is one of the product’s attributes; however, this can be removed as the agency requested. FDA stated that it was okay to leave as is.
 
5) Revise the statement “See attached documents for details” to “See package insert for full prescribing information and instructions for preparation.”
 
Discussion: LifeSouth agreed to remove “see attached document for details” in order to make additional space for the list of additives.
 
6) Provide list of additives/residuals (i.e: DMSO, Dextran, Hetastarch, etc.) expressed as either percentage or absolute volume.  This should be placed below the volume of the unit, such as shown in the example below:
 
Discussion: LifeSouth agreed to include the list of additives on the package label as percentages.
 
Cryopreserved
HPC, Cord Blood
Approx. XX mL (or if volume is consistent then "Approx." can be omitted)
XX% DMSO, XX% DEXTRAN 40, XX% ---(b)(4)-- (or volumes can be used instead of percentages)