
Team Meeting 6, March 25, 2013 - HPC, Cord Blood BLA 125432


 
 
 

DATE:                March 25, 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, Juanita Williams-Gould, Candace Jarvis, Mark Borigini, Loan Nguyen, 

 

 

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

 

Agenda:

 

1.           Administrative Updates
•Review Memos: Due date discussion
•Reviews to Celia: Discussion

2.           Review Updates 

 

a.                CMC:
•Sterility validation update- Still waiting for sponsor to submit outstanding request for information
• Lot Release Exemption

 

b.               DMPQ : 
•Memos will be submitted end of May

c.                PHARM/TOX:
•No New updates

 

d.               CLINICAL: 

              

e.                STATS:
•No New Updates

 

f.                 LABELING:
•Discussion: Timeline for labeling meetings-Decided to discuss offline
• Proprietary Name Review: Letter of denial sent 3/22/13

 

3.           Upcoming Dates:

 

Next team Mtgs: April 22, 2013, May 27, 2013

Completed Review Due: April 5 2013 ( subject to change)

Wrap-Up Mtg: May 21, 2013 (Date subject to change)

Labeling Mtg: TBD

Lot Release Clearance: TBD

Finalized Action Package and Letter: May 17, 2013

Finalized Action Package to Office Director: May 24, 2013

Labeling Teleconference with Sponsor: May 24, 2013

Action Due date: June 17, 2013

 

4.           Other Issues
•SBRA deadline (question)
•Lot Release Exemption deadline

5.           Issues/Questions for sponsor discussion