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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
(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