
Team Meeting 7, April 22, 2013 - HPC, Cord Blood BLA 125432

 
 
 

DATE:                April 22, 2013

Time:                 12:00 -1:00 PM EST

Sponsor:          LifeSouth

BLA #:                              BLA 125432

Product:           HPC, Cord Blood

 

FDA Attendees:          Lillian Ortega; Chad Burger; Joydeep Ghosh; Stephanie Simek; Eric Dollins; Mark Borigini, Mohammed Heidaran; Ilan Irony; Shamsul Hoque; Fatima Abassi; Keith Wonnacott; Stan Lin; Wilson Bryan; 

 

 

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

 

Agenda:

 

1.           Administrative Updates

·                  

2.           Review Updates 

 

a.                CMC:
•Package Insert-Draft PI circulated-Main question-LS for preparation for infusion, CB DSMO not removed –is this a requirement for CB Banks-CB cannot be store is DSMO is removed; ISBT-128 included as well as specific thaw requirements
•Lot Release Exemption:
•SBRA ( draft deadline is April 26, 2013; final deadline May 27, 2013)
•Update on Sterility Validation: LS having issues growing ---(b)(4)---, recent amendment came in that shows growth

 

b.               DMPQ : 
•EIR: May 3rd
•Review memo updates: Toward end of May
•483 response memo: Comment about telecon dates

c.                PHARM/TOX:
•No Updates

d.               CLINICAL: 
•No updates

e.                STATS:
•No updates

 

f.                 LABELING:

 

3.           Upcoming Dates:

 

Next team Mtgs:   May 27, 2013

Completed Review Due: TBD (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
•Draft Review memo updates:
•LS amendments to the EDR: key amendments uploaded
•Labeling Discussions

5.           Issues/Questions for sponsor discussion

                