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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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