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Vaccines, Blood & Biologics

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Record of Telephone Conversation, September 29, 2011 - Ducord

 

Submission Type: BLA    Submission ID: 125407/0    Office: OCTGT
 
Product:
Hematopoietic Progenitor Cells,Cord (HPC-C)
 
Applicant:
Duke University School of Medicine
 
Telecon Date/Time: 29-Sep-2011 10:00 AM        Initiated by FDA? Yes
 
Telephone Number:
 
Communication Categorie(s):
1. Information Request
 
Author: DONNA PRZEPIORKA
 
Telecon Summary: Requested revised dataset.
 
FDA Participants: YY Zhu, D Przepiorka
 
Non-FDA Participants: J Kurtzberg, --(b)(4)(b)(6)--, B Burnette, R Parrish
 
Trans-BLA Group: No
 
 Related STNs: None
 
Related PMCs: None
 
Telecon Body:
Requested revised dataset with missing variables. Discussed what data is actually available. List of variables requested was emailed to the applicant.