Sponsor: New York Blood Center
- Important dates:
- Filing Letter Comments Due: COB, February 28, 2011 (The team agreed to include filing comments in the Day 60 filing letter)
- Filing Letter Finalized: March 11, 2011
- Overview of Application by Discipline: Studies/info submitted; identification of Info Requests; Day 74 letter items
The review team reached an agreement to file the BLA and stated whether or not they had letter comments for the Day 60 filing letter.
- CMC - M. Quagraine; S. Karandish / no filing issues and letter comments
- DMPQ – M. Heidaran & G. Wang/ no filing issues and letter comments
- Pharm/tox – A. Hoque/no filing issues and no letter comments
- Clinical – D. Przepiorka & J. Hyde /no filiing issues and letter comments
- Stats – Rees, Renee /no filing issues and letter comments
- Labeling – L. Stockbridge & L. Nguyen / no filing issues and letter comments
- Epidemiology – A. Ou/ no filing issues and letter comments
- BIMO - C. Jordan & D. Cato / The clinical reviewer stated that since there is no clinical trial; there is nothing for BIMO to inspect.
- Identification of RTF Issues by Discipline
No RTF issues were identified.
- Action Items
- Request CDER consult for clinical team
- Rachel Antol agreed to put BLA on SWAG calendar
- Possible telecon with sponsor to discuss Donor Eligibility
- Patrick Riggins will send email address for E-room.
- Fix roadmap links in EDR
- AC Meeting – Stephanie Simek is waiting for feedback.