• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

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