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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, February 15, 2011 - 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: 15-Feb-2011 11:24 AM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Information Request

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

Related STNs: None
Related PMCs: None
Telecon Body:
______________________________________________
From:                     Gemignani, Helen S 
Sent:                      Tuesday, February 15, 2011 11:24 AM
To:                          'Mulligan Valerie'; 'Mulligan Valerie'; 'Ianacone, John'
Subject:                 Information Request - Viral Harvest Spec

Hi Valerie,

Can you specify the specification for the Viral Harvest Test for -----------(b)(4)--------------------------------------------------------- (pg 6 on the draft LRP)?

No need to amend the BLA. A quick email will suffice.

Many thx,
Helen

Helen Sullivan Gemignani
Regulatory Project Manager
FDA/CBER/OVRR
Division of Vaccines and Related Products Applications/Regulatory Review Branch 2 
(301) 827-3070