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Record of Telephone Conversation - February 23, 2010 - Prevnar 13
System Info - 120984 SMITH, MICHAEL J 23-Feb-2010 21:25:18 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: 23-FEB-2010 09:08 PM Initiated by FDA? Yes
Labeling via FAX/e-mail
Author: JULIENNE VAILLANCOURT
Final draft label
FDA Participants: Julie Vaillancourt, Collen Sweeney and Mike Smith
Non-FDA Participants: Jack Love and Carmel Devlin
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Vaillancourt, Julienne
Sent: Tuesday, February 23, 2010 9:08 PM
To: 'Love Jack'; Devlin Carmel
Cc: Smith, Michael (CBER); Sweeney, Colleen
Subject: Final Approved Draft Labeling
Dear Jack and Carmel,
This is to acknowledge our receipt of revised draft labeling, submitted as an official amendment to the BLA this evening (serial 91, amendment 94). The draft labeling in this amendment replaces the version of the draft labeling received on February 19, 2010, and includes the changes, requested by CBER during the telecon earlier this evening, and thus, is the final approved draft labeling.
Julienne Vaillancourt, R.Ph., M.P.H.
Captain, US Public Health Service
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
US Food and Drug Administration
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