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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, February 26, 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: 26-Feb-2011 04:36 PM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Information Request

Author: HELEN GEMIGNANI
Telecon Summary:
Request for Waiver of Labeling Requirements

FDA Participants: None
Non-FDA Participants: VALERIE MULLIGAN
Trans-BLA Group: No

Related STNs: None
Related PMCs: None
Telecon Body:


From: Valerie Mulligan [mailto:Valerie.Mulligan@tevausa.com]
Sent: Saturday, February 26, 2011 4:36 PM
To: Gemignani, Helen S
Subject: Re: Request for Waiver of Labeling Requirements
We acknowledge receipt of the Agency's request and will prepare the waiver as requested.

Valerie Mulligan
Sr. Director, Regulatory Affairs
Teva Women's Health

215-293-7228