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Vaccines

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

System Info - 100153  SMITH, MICHAEL J  21-Jul-2009 11:37:05  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-JUL-2009 10:00 AM                Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Meeting Request

Author:  MICHAEL SMITH

Telecon Summary:
Telecon w/ Jack Love and Carmel Devlin suggesting a face-to-face meeting to discuss CMC issues related to serotype 5.

FDA Participants:  Michael Smith and Willie Vann

Non-FDA Participants:    Jack Love and Carmel Devlin

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body: 
We called Jack and Carmel and told them that we don't think the CMC issues related to serotype 5 have been adequately addressed-specifically the -------(b)(4)------- issues.  We suggested a face-to-face technical meeting with them in WOC before July 31, so the chemists from Wyeth and CBER can get together and discuss these issues and potentially arrive at a path forward to resolve these issues.  Jack said they would like that opportunity to meet with us and a meeting will be scheduled ASAP. 

 

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