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Vaccines, Blood & Biologics

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

System Info - 100153  SMITH, MICHAEL J  21-Jul-2009 11:37:05  SMITHM


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-JUL-2009 10:00 AM                Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Meeting Request


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. 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 09/25/2013
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