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Record of Telephone Conversation - January 11, 2010 - Prevnar 13
System Info - 116636 SMITH, MICHAEL J 12-Jan-2010 11:23:14 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: 11-JAN-2010 11:27 AM Initiated by FDA? Yes
Author: MICHAEL SMITH
Email: CMC PMC revision regarding the ----(b)(4)--- specification for serotype 1 from ------(b)(4)-----
FDA Participants: Mike Smith, Julie Vaillancourt and Colleen Sweeney
Non-FDA Participants: Jack Love and Carmel Devlin
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Smith, Michael (CBER)
Sent: Monday, January 11, 2010 11:27 AM
To: 'Love Jack'; Devlin Carmel
Cc: Vaillancourt, Julienne; Sweeney, Colleen
Subject: RE: CMC PMC's
Jack and Carmel,
CBER has agreed to your proposed CMC PMC revision regarding the ----(b)(4)----- specification for serotype 1 from -----(b)(4)------.
Mike Smith, Ph.D.
Lieutenant Commander (LCDR), U.S. Public Health Service
Regulatory Project Manager
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
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