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Vaccines

Record of Telephone Conversation, October 22, 2010 - Adenovirus

Submission Type: BLA    Submission ID: 125296/0    Office: OVRR
Product:
Adenovirus Vaccine Live Oral Type 4 and Type 7
Applicant:
Teva Women's Health, Inc.
Telecon Date/Time: 22-Oct-2010 04:15 PM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Information Request

Author: HELEN GEMIGNANI
Telecon Summary:
CMC Information Request
FDA Participants: None
Non-FDA Participants: None
Trans-BLA Group: No

Related STNs: None
Related PMCs: None
Telecon Body:
______________________________________________
From:                     Gemignani, Helen S 
Sent:                      Friday, October 22, 2010 4:15 PM
To:                          'Mulligan Valerie'
Cc:                           'valerie.mulligan@tevausa.com'
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
FDA/CBER/OVRR
Division of Vaccines and Related Products Applications/Regulatory Review Branch 2 
(301) 827-3070