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.
Raj K. Puri, M.D., Ph.D.
Division of Cell and Gene Therapies
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research