Record of Telephone Conversation, April 30, 2012 - ALLOCORD
Submission Type: BLA Submission ID: 125413/0 Office: OCTGT
Hematopoietic Progenitor Cells, Cord (HPC-C)
SSM Cardinal Glennon Children's Medical Center
Telecon Date/Time: 30-Apr-2012 04:00 AM Initiated by FDA? Yes
Author: LEI XU
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
FDA participants asked to clarify the following items in the most recent submission of clinical information dated 4/26/2012.
- The spreadsheet dataset contains patients’ name. Please resubmit the dataset without those names
- Please provide a unique identification number to each patient in the dataset.
- Please clarify the definition of single unit transfusion and multiple units (two or more) transfusion.
- 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.