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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon, January 20, 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: 20-January-2012 1:00 PM        Initiated by FDA? Yes
Telephone Number: -----(b)(4)------
Communication Categorie(s):
Barcode exemption
 
Author: RAMANI SISTA
Telecon Summary:
Barcode Exemption
FDA PARTICIPANTS:
Ramani Sista
Stephanie Simek
Kimberly Benton
 
NON-FDA PARTICIPANTS:
Sharon Miller
 
Trans-BLA Group: No
 Related STNs: None
Related PMCs: None
 

Telecon Body

 

Following introductions, FDA stated that cord blood banks can request exemption from bar code for their BLA applications. ClinImmune can use their ISBT-128 code as their barcode. The Sponsor will have to formally request this exemption. FDA has prepared a template for the exemption request which will be emailed to the Sponsor after the call. The Sponsor will have to add their information and formally submit to the application. The Sponsor agreed to include the exemption in their amendment 4, scheduled to be sent shortly.