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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation - October 21, 2009 - Prevnar 13

System Info - 120671  SMITH, MICHAEL J  21-Feb-2010 11:00:47  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:  21-OCT-2009 01:21 PM                Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  COLLEEN SWEENEY

Telecon Summary:
IR for narratives for all Serious Adverse Events (SAEs), occurring within 30 days following any vaccine dose, regardless of relatedness as determined by the investigator and/or sponsor.

FDA Participants:   Collen Sweeney, Tina Khoie, Julie Vaillancourt and Lucia Lee

Non-FDA Participants:    Carmel Devlin

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

e-mail:

______________________________________________

From:                     Sweeney, Colleen 

Sent:                      Wednesday, October 21, 2009 1:21 PM

To:                          'DEVLINC@wyeth.com'

Cc:                          Khoie, Tina; Vaillancourt, Julienne; Lee, Lucia

Subject:                RE: Information Request for SAE reports

FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

Memorandum

Date:October 21, 2009
To:

Carmel Devlin, Associate Director
Global Regulatory Affairs,
Wyeth Pharmaceuticals Inc.

From:CDR C. Sweeney, MS, Regulatory Coordinator
CC:

Tina Khoie, M.D., M.P.H., Clinical Reviewer
Lucia Lee, M.D., Team Leader, VCTB, DVRPA
Julienne Vaillancourt, R.Ph.,M.P.H.,Chair

Subject:CBER Comments on STN 125324

Please respond to Dr. Tina Khoie’s request below for the following additional information:

1. Please submit narratives for all Serious Adverse Events (SAEs), occurring within 30 days following any vaccine dose, regardless of relatedness as determined by the investigator and/or sponsor.

 

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