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
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 21-OCT-2009 01:21 PM Initiated by FDA? Yes
Author: COLLEEN SWEENEY
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
From: Sweeney, Colleen
Sent: Wednesday, October 21, 2009 1:21 PM
Cc: Khoie, Tina; Vaillancourt, Julienne; Lee, Lucia
Subject: RE: Information Request for SAE reports
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
|Date:||October 21, 2009|
|From:||CDR C. Sweeney, MS, Regulatory Coordinator|
|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.