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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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448