- 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.
- 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
- 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