
Team Meeting 8, May 30, 2013 - HPC, Cord Blood BLA 125432


 
 

DATE:                May 30, 2013

Time:                 12:00 -1:00 PM EST

Sponsor:          LifeSouth

BLA #:                              BLA 125432

Product:           HPC, Cord Blood

 

FDA Attendees:          Mohammed Heidaran, Eric Dollins, Stephanie Simek, Kimberly Benton, Joydeep Ghosh, Shamsul Hoque, Ilan Irony, Wilson Bryan, Stan Lin, , Candace Jarvis, Mark Borigini, Loan Nguyen, Keith Wonnacott, Lillian Ortega, Marion Michaelis, Chad Burger, Fatima Abbasi,

 

 

Call in information:  ---------(b)(4)---------------------------------------

 

Agenda:

 

1.           Administrative Updates

2.           Review Updates

 

a.                CMC:
•Lot Release Exemption sent to Karen Campbell
•Unicode
•Barcode exemption sent in March

 

b.               DMPQ : 
•Review Memos submitted by June 11th
•Will perform compliance check           

c.                PHARM/TOX:
•No New updates

 

d.               CLINICAL: 
•Revisions to Package Insert
•Waiting on response to explanation sent to LS regarding data provided in PI

e.                STATS:
•No New Updates

 

f.                 LABELING:
•Package and container Labels under review
•Package Insert revisions

 

3.           Upcoming Dates:

 

Next team Mtgs: NA

Completed Review Due: TBD (subject to change)

Wrap-Up Mtg: NA

Labeling Mtg: TBD (case by case)

Lot Release Clearance: Completed

Finalized Action Package and Letter: 

Finalized Action Package to Office Director: 

Labeling Teleconference with Sponsor: 

Action Due date: June 17, 2013

 

4.           Other Issues
•SBRA : draft circulating
•Draft approval letter: circulating
•PI under second revision, will send to firm by end of week
•Applicant agreed to the changes for the package and container label; additional questions about Hetastarch

5.           Issues/Questions for sponsor discussion
•Hetastarch
