Submission Type: BLA Submission ID: 125296/0 Office: OVRR
Adenovirus Vaccine Live Oral Type 4 and Type 7
Teva Women's Health, Inc.
Telecon Date/Time: 22-Oct-2010 04:15 PM Initiated by FDA? Yes
1. Information Request
Author: HELEN GEMIGNANI
CMC Information Request
FDA Participants: None
Non-FDA Participants: None
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Gemignani, Helen S
Sent: Friday, October 22, 2010 4:15 PM
To: 'Mulligan Valerie'
Subject: Adenovirus BLA STN 125296/0 - CBER Information Request
CBER has the following comments pertaining to your September 21, 2010, resubmission of your BLA:
1. Regarding your response to item 2d of CBER’s Complete Response (CR) letter dated July 16, 2009, please clarify if you have revised your SOP for inspecting the incoming bulk viral bottles and proper handling of non-conformance samples should the “hissing bottle” or similar incident recur.
2. Please submit an update report from ---(b)(4)--- on commitments made in their 483 responses to correct the deficiencies identified in the FDA Form 483 issued on February 17, 2009, and include the status of responding to those commitments within the specified timeframe.
3. We note that the Identity test assay has changed since the first review cycle of this BLA. Please confirm that there have been no other tests revised from the original submission that FDA needs to assess.
Please submit a response to these items as an amendment to the BLA. If you have any questions, or need additional information, please feel free to contact me.
Helen Sullivan Gemignani
Regulatory Project Manager
Division of Vaccines and Related Products Applications/Regulatory Review Branch 2