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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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