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
