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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Team Meeting 3, August 27, 2012 - HPC, Cord Blood BLA 125432

 

Monthly Team Meeting #3
 
DATE:                August 27, 2012
Time:                 12:00 -1:00 PM EST
Sponsor:          LifeSouth
BLA #:                              BLA 125432
Product:           HPC, Cord Blood
 
FDA Attendees:          Candace Jarvis, Mohammed Heidaran, Juanita Williams-Gould, Grace Deneke, Atm S.Hoque, , Stan Lin, , Karoll Cortez, Keith Wonnacott, Loan Nguyen, , Jalal Sheikh, Wilson Bryan, Kimberly Benton, Lillian Ortega, , Ted Stevens, Eric Dollins,
 
 
Call in information:  ------------(b)(4)-------------------------
 
Agenda:
 
1.           Administrative Updates
·                 None at this time
 
2.           Review Updates
 
a.                CMC:
·                 Information Request letter sent to the sponsor on 8/22/12;
t-con with sponsor on 8/28/2012 (validation, test methods,            flow cytometry
·                 No responses for 7/16/12 Filing/Deficiency letter received
as of yet
·                 Inform sponsor to submit responses in a timely fashion, ok to
accept partial responses –Mo to follow-up with sponsor.
·                 Noted in review that there are no SOPs for assay validation,
asked sponsor in 8/22/12 letter to provide a brief description of assays, and validations performed and to submit SOPs.
 
b.               DMPQ : 
·                 Clarification on capacity issues cleared up with sponsor on 7/20/12 in t-con: the sponsor stated that their maximum capacity is ---(b)(4)---. When we indicated that we would need to observe during the inspection manufacturing at maximum capacity for which approval is being sought. LifeSouth indicated that they could only demonstrate(b)(4) on inspection. After discussing this subject of capacity with DMPQ management it was determined that we need to have additional conversation with the firm
c.                PHARM/TOX:
·                 No new updates
 
d.               CLINICAL: 
·                 No new updates
 
e.                STATS:
·                 Consulting with clinical; deficiencies documented in 7/16/12 letter no new issues noted
 
f.                 LABELING:
·                 No new updates
·                 PI submitted; question on sponsor proprietary name- to follow-up with sponsor in t-con
 
3.           Upcoming Dates:
 
Next team Mtg: September 24, 2012
 
Mid-Cycle review: Draft memos due to Celia by 10/11/12; meeting 10/18/12
 
4.           Other Issues
 
5.           Issues/Questions for sponsor discussion