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Mid-Cycle Review Meeting Minutes, June 10, 2011 - Hemacord
Mid-Cycle Review Meeting Minutes
Sponsor: New York Blood Center
BLA #: BLA 125397
Product: Hematopoietic stem/progenitor cells, cord (HPC-C)
Date: June 10, 2011
Time: 2:30PM -4:00PM
Meeting Attendees: Thomas, Terrolyn; Witten, Celia; Bryan, Wilson; Przepiorka, Donna;; Nguyen, Loan; Stockbridge, Lisa L; Heidaran, Mohammad; Wang, Gang; Serabian, Mercedes; Hoque, Atm S.; Wonnacott, Keith; Quagraine, Mercy; Karandish, Safa; Wise, Robert; Riggins, Patrick; Puri, Raj K. Benton, Kimberly; Bross, Peter; Joshi, Bharat; Rees, Renee; Hyde, John E; Bauer, Steven; McCright, Brenton; Norwood, Laurie; Ghosh, Joydeep; Lazarus, Ellen;; Stevens, Ted; Bi, Lilia Lei; Witten, Rachel; Dapolito, Gail; Fan, Yong
2. Important dates
Draft FDA Briefing Document
Due to Supervisors: COB, July 8, 2011
Primary Reviews Due: COB, August 18, 2011
PDUFA GOAL Date: November 10, 2011
3. Discipline Specific Reviews of Application (handouts provided)
- CMC - M. Quagraine; B. McCright; B. Joshi; S, Bauer; J. Ghosh; S. Karandish
Requested teleconference with sponsor to discuss outstanding issues.
- DMPQ – M. Heidaran & G. Wang
Requested teleconference with sponsor to discuss outstanding issues (483 citation update ; quality and batch record verification by August 1,2011).
- Clinical – D. Przepiorka & J. Hyde
Team will move forward with PeRc waiver. OCTGT Director, Dr Witten stated that OBE needs to review the data; OBE reviewer should be invited back to review team.
- Labeling – L. Stockbridge & L. Nguyen
Noted that mock package insert was sent to sponsor.
4. Issues Requiring Resolution
- It was indicated that additional Malignancy and Metabolic Hematology Disease Specialist should be added to Advisory Committee panel.
- DMPQ will review the DCGT recommendation on NYBC’s sample retention management for adequacy and update management
5. Scheduled Meetings
- Advisory Committee Meeting: September 22, 2011
- Wrap-UP Meeting: October 6, 2011
- Labeling Meeting: TBD
- Team Meeting: June 21, 2011
- Sponsor Meeting to Discuss Outstanding Issues: June 20, 2011