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Vaccines, Blood & Biologics
DATE: June 25, 2012
Time: 12:00 -1:00 PM EST
BLA #: BLA 125432
Product: HPC, Cord Blood
FDA Attendees: Candace Jarvis, Mohammed Heidaran, Williams-Gould, Juanita; Deneke, Grace; Hoque, Atm S.; Serabian, Mercedes; Lin, Stan; Zhen, Boguang (CBER); Cortez, Karoll; Wonnacott, Keith; Nguyen, Loan; Stockbridge, Lisa L; Sheikh, Jalal; Ghosh, Joydeep; Borigini, Mark; Haudenschild, Changting; Irony, Ilan; Bryan, Wilson; Simek, Stephanie; Benton, Kimberly; Puri, Raj K. (FDA/CBER); Hall, Angela; Michaelis, Marion; Syin, Chiang; Ortega, Lillian; Holobaugh, Patricia; Karandish, Safa; Witten, Celia (CBER); Riggins, Patrick; Tull, Lori; Liu, Ke; Stevens, Ted
Call in information: -------------------(b)(4)----------------------
1. Review Updates
· Submission ok- suitable for reviewing
· Confirmed that LifeSouth intends to use ISBT-128
· Regional Storage Facility for Collecting cord blood to be evauated by DMPQ. It is not clear if the temp storage sites need to be registered or inspected.
· DE, no filing issues but a lot of work need to be done(Later)
· Confirmed that it is ok to go ahead with planning pre-license inspection for September.
· DMPQ will follow up with ---(b)(4)--- issues related to ---(b)(4)--
· DMPQ and Mo to exchange information about the exact software used for Cord Blood Banking.
· Deficiency- Lifesouth has not done a media fill for process validation. This is not a filing issue.
· No issues
· Missing data in submission: diagnosis, dosing, PBHD cell counts, CCN numbers, death, etc.--- have not followed recommendations in pre-BLA
· Insufficient data to review; a comment will be included in the filing letter requesting additional information.
· There is not a filing issue
· No issues
· Package label: a lot of work need to be done(Later)
· Instruction for preparation of cord blood missing (Not urgent); this can be requested later in the review.
· ISBT-128 label Requirements
2. Filing Meeting
Mtg Date: July 2, 2012
Filing Letter Action/Comments: COB, Tuesday, July 10, 2012
Filing Letter: Tuesday, July 17, 2012
· Comments to be added to the filing letter
3. Other Issues
4. Issues/Questions for sponsor discussion