
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

 