Date/Time of Call: August 2, 2011 10:25am
CBER Representative: Sonday L. Kelly, M.S., CBER/OBRR/DBA
Organization Representative: Sara Horn, Ph.D.
Organization: Omrix Biopharmaceuticals, Ltd.
FDA Initiated: No
Subject: Request for teleconference
STN: BL 125392/0
- Dr. Horn called to ask if there is any outstanding information that needs to be submitted to this original BLA. Omrix has responded to all Information Requests (IR) except for the most recent request for a Lot Release Plan.
- Omrix requested a teleconference with DMPQ reviewers to discuss their recently received Form FDA 483. Omrix plans to address the 483 as a postmarketing commitment and would like to gain clarification on the items listed on the form.
- Omrix requested a teleconference with CMC reviewers to discuss “post-approval changes” to the Fibrin Pad and comparability studies to make sure they are on the right track.
Dr. Horn noted that the PDUFA goal date is approaching and the firm has not been contacted by the FDA to negotiate labeling. I informed her that any additional requests for information would be forwarded to Omrix through their U.S. representative, --b(4)-----