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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Team Meeting 1, June 25, 2012 - HPC, Cord Blood BLA 125432

 

DATE:                June 25, 2012
Time:                 12:00 -1:00 PM EST
Sponsor:          LifeSouth
BLA #:                              BLA 125432
Product:           HPC, Cord Blood
 
FDA Attendees:          Candace Jarvis, Mohammed Heidaran, Williams-Gould, Juanita; Deneke, Grace; Hoque, Atm S.; Serabian, Mercedes; Lin, Stan; Zhen, Boguang (CBER); Cortez, Karoll; Wonnacott, Keith; Nguyen, Loan; Stockbridge, Lisa L; Sheikh, Jalal; Ghosh, Joydeep; Borigini, Mark; Haudenschild, Changting; Irony, Ilan; Bryan, Wilson; Simek, Stephanie; Benton, Kimberly; Puri, Raj K. (FDA/CBER); Hall, Angela; Michaelis, Marion; Syin, Chiang; Ortega, Lillian; Holobaugh, Patricia; Karandish, Safa; Witten, Celia (CBER); Riggins, Patrick; Tull, Lori; Liu, Ke; Stevens, Ted
 
Call in information:  -------------------(b)(4)----------------------
 
Agenda:
 
1.           Review Updates
 
a.                CMC:
·       Submission ok- suitable for reviewing
·       Confirmed that LifeSouth intends to use ISBT-128
·       Regional Storage Facility for Collecting cord blood to be evauated by DMPQ. It is not clear if the temp storage sites need to be registered or inspected.
·       DE, no filing issues but a lot of work need to be done(Later)
 
b.               DMPQ
·       Confirmed that it is ok to go ahead with planning pre-license inspection for September.
·       DMPQ will follow up with ---(b)(4)--- issues related to ---(b)(4)--
·       DMPQ and Mo to exchange information about the exact software used for Cord Blood Banking.
·       Deficiency- Lifesouth has not done a media fill for process validation. This is not a filing issue.
 
c.                PHARM/TOX
·       No issues
 
d.               CLINICAL
·       Missing data in submission: diagnosis, dosing, PBHD cell counts, CCN numbers, death, etc.--- have not followed recommendations in pre-BLA
·       Insufficient data to review; a comment will be included in the filing letter requesting additional information.
·       There is not a filing issue
 
e.                STATS
·       No issues
 
f.                 LABELING
·       Package label: a lot of work need to be done(Later)
·       Instruction for preparation of cord blood missing (Not urgent); this can be requested later in the review.
·       ISBT-128 label Requirements
 
2.               Filing Meeting
 
Mtg Date: July 2, 2012
Filing Letter Action/Comments: COB, Tuesday, July 10, 2012
Filing Letter: Tuesday, July 17, 2012
·       Comments to be added to the filing letter
 
3.           Other Issues
4.           Issues/Questions for sponsor discussion