Initial Filing Review Letter, December 20, 2011 - 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                                                                           
 
SSM Cardinal Glennon Children's Medical Center
Attention: Dr. William S Ferguson
SSM Cardinal Glennon Children's Medical
1465 South Grand Boulevard
St. Louis, MO 63104
 
Dear Dr. Ferguson:
 
This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.
 
We have completed an initial review of your application dated October 19, 2011 for Hematopoietic Progenitor Cells, Cord (HPC-C) to determine its acceptability for filing. Under 21 CFR 601.2(a) we have filed your application today. The review goal date is August 20, 2012. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted. 
 
We will contact you regarding your proposed labeling no later than July 21, 2012. If postmarketing study commitments (506B) are required, we will contact you no later than July 21, 2012.
 
Please refer to our October 31, and December 5, 13 and 14, 2011 emailed requests for additional information. At this time, we have not identified any additional potential review issues. Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application. Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.
 
If you have any questions, please contact the Regulatory Project Manager, Lori A. Tull, at (301) 827-5359.
 
Sincerely yours,
 
 
Raj K. Puri, M.D., Ph.D.
Director
Division of Cellular and Gene Therapies
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research