
Wrap up Meeting Agenda, May 21, 2013 - HPC, Cord Blood BLA 125432

 
 
 

Sponsor:          LifeSouth

BLA #:                              BLA 125432

Product:           HPC, Cord Blood

Time:                 1:00-2:00 PM 

 

Meeting Attendees: Candace Jarvis, Juanita Williams-Gould, Mohammed Heidaran, Eric Dollins, Karoll Cortez, , Mark Borigini, , Shamsul Hoque, Loan Nguyen, , , Marion Michaelis, Joydeep Ghosh, , Lillian Ortega, Patricia Holobaugh, Ilan Irony, Wilson Bryan, Stephanie Simek, Kimberly Benton, , Ted Stevens

 

 

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

 

1.              Important dates

PDUFA GOAL Date:     June 17, 2013

 

2.             Discussion of Package Insert

 

http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM356893.pdf