Major Admendment Letter, February 15, 2013 - HPC, Cord Blood BLA 125432
Our STN: BLA125432/0
LifeSouth Community Blood Centers, Inc
Attention: Nancy Eckert
4039 Newberry Road
Gainesville, FL 32607
Dear Ms. Eckert:
We received your January 30, 2013 amendment to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act (42 U.S.C. 262) for Hematopoietic Progenitor Cells, Cord Blood (HPC-C) on January 31, 2013.
We consider your submission a major amendment under the reauthorization of the prescription drug user fee program in the Food and Drug Administration Amendments Act of 2007.
Because we received this major amendment within three months of the action due date, we will add an additional three months to the time by which we should complete our review. Therefore, the action due date is June 17, 2013
If you have any questions, please contact the Regulatory Project Manager, Candace Jarvis at (301) 827-6536.
Raj K. Puri, M.D., Ph.D.
Division of Cellular and Gene Therapies
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research