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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation - September 25, 2009 - Prevnar 13

System Info - 106057  SMITH, MICHAEL J  28-Sep-2009 14:26:31  SMITHM

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125324/0    Office: OVRR  

Product:
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Applicant:
Wyeth Pharmaceuticals Inc.          

Telecon Date/Time:  25-SEP-2009 06:00 PM     Initiated by FDA?  Yes
Telephone Number:  845-536-3217

Communication Categorie(s):
Advice

Author:  MICHAEL SMITH

Telecon Summary:
CBER informed Jack Love that the tentative closed session for the November 18, 2009, VRBPAC is canceled.

FDA Participants:   Marion Gruber, Julie Vaillancourt and Mike Smith

Non-FDA Participants:    Jack Love

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

CBER informed Jack Love that the tentative closed session for the November 18, 2009, VRBPAC is canceled.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002