Product: HPC, Cord Blood
Applicant: LifeSouth Community Blood Centers, Inc.
Telecon Date/Time: 27-Mar-2013 11:00 AM Initiated by FDA? Yes
Telephone Number: --------------------(b)(4)-------------------------
Communication Categorie(s): 1. Advice2. PNR Non-Acceptance3. Information Request
Author: CANDACE JARVIS
Telecon Summary: FDA requested a brief teleconference to discuss the company's proprietary name review request (amd 13)
FDA Participants Mohammad Heidaran, Ph.D., Biologist (CBER/OCTGT/DCGT)
Eric Dollins, Ph.D., Biologist (CBER/OCTGT/DCGT)
Candace Jarvis, B.S., CSO (CBER/OCTGT/RMS)
Kimberly Benton, Ph.D., Deputy Director (CBER/OCTGT/DCGT)
Lori Masingil (Technical Communications Manager)
Amy Lambert, (Manager Cellular Therapies)
Luis Hernandez (QA Coordinator)
Edward Downey (Administrative Laboratory Manager)
Evan Basler (QA Regulatory Coordinator)
Jessica Drouillard (Laboratory Training Coordinator
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:FDA requested a brief telecon with Life South to discuss the proprietary name review for the BLA. It was asked had the company received the recent Proprietary Name Review-Non-Acceptance letter that was faxed to them on March 22, 2013. The sponsor expressed that they had not received the fax. (Note: Candace Jarvis refaxed the letter to the sponsor during the t-con).
In the interim, a copy of the letter was read to the sponsor and it was expressed to them that it was their option to resubmit a new proprietary name request for review; however, it is not necessary and the generic name HPC, Cord Blood could be used. However, whatever their decision would be they had to submit it in writing to the agency as to whether they would or wouldn’t be requesting proprietary name review again.
FDA also requested that the sponsor submit their Package Insert for review in word format. The sponsor agreed.