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Vaccines, Blood & Biologics
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125391/0 Office: OCTGT
Hematopoietic Progenitor Cells,Cord (HPC-C)
Telecon Date/Time: 27-Jun-2011 02:00 PM Initiated by FDA? Yes
Telephone Number: ----(b)(4)----, Participant PIN is: ---(b)(4)---
1. Information Request
Author: RAMANI SISTA
Product clarification of earlier IR
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Following introductions, the product team stated that this call was primarily to follow up on the status of product and clinical requests made in the teleconferences dated May 31 and June 14. The Sponsor responded that they were planning to submit the requested information as amendment 1 to the BLA on June 28. The Sponsor also stated that the contract lab information requested by the product reviewer was not available since the lab refused to provide it. The requested information is very large in volume and the contract lab is not willing to share it with the Sponsor. The FDA reiterated that their request is reasonable and the team is looking for a summary of the data, not the entire data. The FDA also informed the Sponsor that they will need to review and inspect the contract lab information as an essential part of their BLA application.
Regarding Licensure inventory, the FDA stated that at this point, it would be easier to look at all the information the Sponsor provided in their application and license units produced recently. The FDA team will be inspecting the facility as per requirement for licensure, at that point they can also look at all the available information for older units and based on their findings, the Sponsor may be able to request licensure for older units in subsequent supplements to BLA.