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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Team Meeting 4, November 26, 2012 - HPC, Cord Blood BLA 125432

 

DATE:                November 26, 2012
Time:                 12:00 -1:00 PM EST
Sponsor:          LifeSouth
BLA #:                              BLA 125432
Product:           HPC, Cord Blood
 
FDA Attendees:          Candace Jarvis, Mohammed Heidaran, Juanita Williams-Gould, CHad Burger, Atm S.Hoque, , Stan Lin, , Karoll Cortez, Keith Wonnacott, Lisa Stockbridge, , Joydeep Ghosh, Wilson Bryan, Kimberly Benton, Lillian Ortega, , Fatima Abassi, Eric Dollins, Stephanie Simek, Celia Witten, Mark Borigini, Changting Haudenschild, Raj Puri,
 
 
Call in information:  -------------(b)(4)------------------------
 
Agenda:
 
1.           Administrative Updates
  • None at this time
 
2.           Review Updates
 
a.                CMC:
Outstanding issues: 
  • Donor screening SOPs need to be revised to provide detail information regarding review of the medical and physical examination records
  • Collection validation information not adequate. The applicant has not provided all the data; doable in a short period of time
  • The applicant must provide information regarding the assignment of unique donor identification and maintaining linkage between the collected unit and the birth mother; doable in a short period of time
  • The applicant must provide analytical specificity and analytical sensitivity for CD34 and nRBC enumeration laboratory validated tests; (higher limit of detection need to be shown); doable in a short period of time
  • In regard to ---(b)(4)--- sterility test method validation, the adequacy of the sampling plan for the final product has not been adequately established; sponsor to submit validation plans for preview/comments; need to determine if the sponsor plans to exclude birth mothers on antibiotics.
  • Package label is not in compliance with ISBT requiring bar codes
Update: Sponsor plan to fully implement ISBT 128 by 12/30/12
  • Request for proprietary name is outstanding
Update: Sponsor plan to submit proprietary name request after approval.
  • Revalidation of the Emergency recovery remains to be performed.
 
b.               DMPQ : 
  • Sponsor states that they are planning renovation of clean rooms on 11/27/12. Not too sure of flooring they are going to use as it is listed as industrial grade clean room flooring from a tile company; however, the owness for their choice of flooring belongs to them. Once renovations are complete, they will need to re-qualify the room. 
  • Main issue: seems to be executing the qualifying of the cleaning and identifying organisms and growth promotion; they also need to qualify new equipment. 
  • End of January beginning of February seems to the target for resolving the facility issue
 
c.                PHARM/TOX:
  • No new updates
 
d.               CLINICAL: 
  • Sponsor submitted the appropriate HLA matching data, appears to be adequate.
 
e.                STATS:
  • Created a table showing the number of subjects achieving ANC>500 by day 42 cross classified by HLA match and TNC Dose (X107/kg).
 
f.                 LABELING:
  • No new updates
 
3.           Upcoming Dates:
 
Next team Mtg: January 7, 2013
Completed Review Due: January 17, 2013
Wrap-Up Mtg: February 19, 2013 (Date subject to change)
Labeling Mtg: TBD
 
4.           Other Issues
  • Timelines submitted by sponsor-Upper Mgmt discussion needed
  • Determination of Major Amendment for outstanding items submitted by sponsor and clock extension option
  • Determination of CR letter issuance.
5.           Issues/Questions for sponsor discussion
  • Inform sponsor that when submitting amendments to the BLA, inspectional findings need to be separated from review related issues.
Update: sponsor informed in 11/28/12 t-con