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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resubmission Acknowledgement Letter, January 4, 2013 - ALLOCORD

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 

Our STN: BL 125413/0                                                                     January 4, 2013
 
SSM Cardinal Glennon Children's Medical Center
Attention: Ms. Donna M Regan
3662 Park Avenue
St. Louis, MO 63110
 
Dear Ms. Regan:
 
We have received your December 13, 2012 resubmission to your biologics license application for HPC, Cord Blood on December 14, 2012.
 
The resubmission contains additional responses to the 483 items, responses to CMC items, and withdrawal of the St. Luke's Cancer Center site that you submitted in response to our August 16, 2012 complete response letter. 
 
We consider this a complete response to our action letter. Therefore, the goal date is June 15, 2013.
 
If you have any questions, please contact the Regulatory Project Manager, Lori A. Tull, at 827-5359.
 
Sincerely yours,
 
 /s/
 
Raj K. Puri, M.D., Ph.D.
Director
Division of Cell and Gene Therapies
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research