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Vaccines, Blood & Biologics

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Record of Telephone Conversation, April 30, 2012 - ALLOCORD

 

Submission Type: BLA    Submission ID: 125413/0    Office: OCTGT
Product:
Hematopoietic Progenitor Cells, Cord (HPC-C)
Applicant:
SSM Cardinal Glennon Children's Medical Center
Telecon Date/Time: 30-Apr-2012 04:00 AM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Advice
 
Author: LEI XU
Telecon Summary:
Clarification of the applicant submitted clinical information (4/27/2012)
FDA Participants: Lei Xu, Renee Reese
Non-FDA Participants: Donna Regan, Kathy Fortune, Kris Wassmer, Hui Xu
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
FDA participants asked to clarify the following items in the most recent submission of clinical information dated 4/26/2012.
  1. The spreadsheet dataset contains patients’ name. Please resubmit the dataset without those names
  2. Please provide a unique identification number to each patient in the dataset.
  3. Please clarify the definition of single unit transfusion and multiple units (two or more) transfusion.
  4. Periodic adverse experience reports (21CFR 600.80 c(2)) is not present in the SOPP QM04.04: Occurrence Report Policy. Please revise the SOP in accordance with 21 CFR 600.80 Postmarketing reporting of adverse experiences.