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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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