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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, January 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-Jan-2011 04:08 PM        Initiated by FDA? Yes
Communication Category:  Information Request
Author: HELEN GEMIGNANI

Telecon Summary: Certificate of Compliance Form 3674
FDA Participants: Helen Gemignani
Non-FDA Participants: Valerie Mulligan
Telecon Body:

Please review your Certificate of Compliance Form 3674 and review whether it would be appropriate to check choice "C" in #9 and subsequently prudent to list the NCT number for #10.