
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

 